25
May 2017

CPhI’s 2nd Annual CAPA & Root Cause Investigation Workshop

Date: 25-26 May 2017
Venue: Mumbai



Navitas along with Sparta Systems is exhibiting at CAPA & Root Cause Investigation Workshop. CPhI’s CAPA & Root Cause Investigation Workshop is the only forum in India dedicated to identifying non-compliance, understanding the root cause, and responding with appropriate corrective and preventive actions for the Pharmaceutical companies. It is an exclusive workshop mentored by Former USFDA Director on areas of quality and manufacturing in Pharma companies with focus on USFDA’s Quality System Guide, recent Warning Letters and EU-GMP Chapter 1 regulations.

If you would like further information, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

07
Jun 2017

pvnet Strategic Summit - Spring

Date: 07 June 2017
Venue: New York
labelnet



Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

The Spring agenda will focus on implementation of innovation ideas, with a focus on the role of technology and new sources of data.

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

07
Jun 2017

pvconnect Forum - Spring

Date: 07 June 2017
Venue: New York
labelnet



Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

Agenda topics for Spring 2017 will include the need to balance compliance with agility; our London forum will be centred on QPPV-related discussions.

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

07
Jun 2017

labelnet Forum - Spring

Date: 07 June 2017
Venue: New York
labelnet



Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

The Spring agenda will focus on smart labeling and will include smart strategy (development labeling and local intelligence), smart resources (outsourcing and key labeling roles) and smart management (labeling across sectors and back end of the E2E process) and smart technology (one day technology showcase on labeling and RIM key tools and systems (in London only)

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

07
Jun 2017

cmonet strategic summit

Date: 07 June 2017
Venue: New York
labelnet



cmonet was launched in 2014 and since then twenty CMOs from a range of large and medium pharmas and biotechs have participated. Fifteen CMOs completed a survey on the evolving role of the CMO. Three face-to-face meetings have taken place with member-led agendas relating to challenges in common and the evolving context.

For more information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

08
Jun 2017

pvtech Forum - Spring

Date: 08 June 2017
Venue: New York
pvtech



pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.

We will be looking at how to increase business value from PV technology investments, as well as delivering new insights and new methods of handling the ever increasing work load, requirements and complexities.

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

08
Jun 2017

rimnet Forum - Spring

Date: 08 June 2017
Venue: New York
rimnet



Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.

This forum is now a full network focusing on global RIM implementation to provide a platform to discuss organisation, process and technology aspects.

For further information or to register to attend please contactThis email address is being protected from spambots. You need JavaScript enabled to view it.

14
Jun 2017

pvtech Forum - Spring

Date: 14 June 2017
Venue: London
pvtech



pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.

We will be looking at how to increase business value from PV technology investments, as well as delivering new insights and new methods of handling the ever increasing work load, requirements and complexities.

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

15
Jun 2017

pvconnect forum spring London

Date: 15 June 2017
Venue: London
labelnet



Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

Agenda topics for Spring 2017 will include the need to balance compliance with agility; our London forum will be centred on QPPV-related discussions.

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

21
Jun 2017

DIA 2017 Annual Meeting

Date: 21st June 2017
Venue: Chicago, IL
DIA 2017 Annual Meeting



Navitas presents at DIA Annual Meeting in Chicago.

Principal Consultant Jeffrey Ho will present “Successes and Challenges in Achieving and Maintaining Oversight of Pharmacovigilance Affiliates” at DIA’s annual meeting in Chicago, IL at 10:30am on June 21st.

Jeffrey is part of a panel session titled “The Brave New World: The Ongoing Globalization of Pharmacovigilance”. Additional panelists include the Global Head of Pharmacovigilance and Medical Affairs from Otsuka Pharmaceuticals.

For more information on the sessions, click here.

To arraign a meeting with Navitas pharmacovigilance experts, click This email address is being protected from spambots. You need JavaScript enabled to view it..

07
Nov 2017

pvnet Summit – Autumn

Date: 07 November 2017
Venue: London
labelnet



Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

The Spring agenda will focus on implementation of innovation ideas, with a focus on the role of technology and new sources of data.

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

07
Nov 2017

rimnet Forum - Autumn

Date: 07 November 2017
Venue: London
rimnet



Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.

This forum is now a full network focusing on global RIM implementation to provide a platform to discuss organisation, process and technology aspects.

For further information or to register to attend please contactThis email address is being protected from spambots. You need JavaScript enabled to view it.

08
Nov 2017

pvtech Forum - Autumn

Date: 08 November 2017
Venue: London
pvtech



pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.

We will be looking at how to increase business value from PV technology investments, as well as delivering new insights and new methods of handling the ever increasing work load, requirements and complexities.

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

08
Nov 2017

labelnet Forum - Autumn

Date: 08 November 2017
Venue: London
labelnet



Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

09
Nov 2017

pvconnect Forum - Autumn

Date: 09 November 2017
Venue: London
labelnet



Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

14
Nov 2017

pvnet Summit – Autumn

Date: 14 November 2017
Venue: New York
labelnet



Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

The Spring agenda will focus on implementation of innovation ideas, with a focus on the role of technology and new sources of data.

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

14
Nov 2017

rimnet Forum - Autumn

Date: 14 November 2017
Venue: New York
rimnet



Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.

This forum is now a full network focusing on global RIM implementation to provide a platform to discuss organisation, process and technology aspects.

For further information or to register to attend please contactThis email address is being protected from spambots. You need JavaScript enabled to view it.

15
Nov 2017

pvtech Forum - Autumn

Date: 15 November 2017
Venue: New York
pvtech



pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.

We will be looking at how to increase business value from PV technology investments, as well as delivering new insights and new methods of handling the ever increasing work load, requirements and complexities.

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

15
Nov 2017

labelnet Forum - Autumn

Date: 15 November 2017
Venue: New York
labelnet



Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

15
Nov 2017

PV Technology Showcase

Date: 15 November 2017
Venue: New York
pvtech



Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

16
Nov 2017

pvconnect Forum - Autumn

Date: 16 November 2017
Venue: New York
labelnet



Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

24
May 2017

Webinar - FDA’s Requirements for eCTD Submissions

Date: Wednesday 24th May 2017
Time: 2 PM EST



Webinar will cover:

  • New regulatory requirements – and their advantage
  • Organizational challenges
  • How to prepare – quickly – for submitting applications electronically
  • Document granularity considerations
  • What to do with legacy documents
  • Document templates – not optional
  • How to use the FDA’s Gateway and more
To register please click here

For further information please email This email address is being protected from spambots. You need JavaScript enabled to view it.

18
May 2017

rimnet Forum - Spring

Date: 18 May 2017
Venue: London
rimnet



Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.

This forum is now a full network focusing on global RIM implementation to provide a platform to discuss organisation, process and technology aspects.

For further information or to register to attend please contactThis email address is being protected from spambots. You need JavaScript enabled to view it.

16
May 2017

labelnet Forum - Spring

Date: 16-17 May 2017
Venue: London
labelnet



Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

The Spring agenda will focus on smart labeling and will include smart strategy (development labeling and local intelligence), smart resources (outsourcing and key labeling roles) and smart management (labeling across sectors and back end of the E2E process) and smart technology (one day technology showcase on labeling and RIM key tools and systems (in London only)

For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

08
May 2017

Webinar hosted by Navitas Networks: Evolving IDMP Guidelines

Date: Monday 8th May 2017
Time: 15:30 – 17:00 GMT



We are pleased to announce the next Navitas Networks Webinar is taking place on 8th May & will be presented by Gary Aldam and Mayank Raizada

Agenda:

  • The evolving IDMP guidelines
  • Key requirements
  • Expected timelines
  • What it means in reality?
  • 5 steps to IDMP readiness – a pyramid for success
  • Data management
  • Governance, Organisation
  • Process and Technology
  • So what and where next?
  • Benefit or burden?
  • Where will it lead?
  • Q & A, Close
To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

04
May 2017

Webinar hosted by Navitas Networks: Transitioning into a new era of Risk Management in Europe

Date: Thursday 4th May 2017
Time: 15:30-17:00 GMT



Agenda:

  • Update on Risk Management in Europe
  • Overview of RM in EU
  • Summary of GVP V and VXI changes
  • Practical application: What does it mean?
  • Focus of the implementation taskforce
  • Maintaining the EU norm through change
  • Understanding the scientific shift in RM
  • Transitioning to the revised template
  • Updating the QMS
  • Global impact
To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

25
Apr 2017

eRegulatory Summit

Date: 25-27 April 2017
Venue: Hotel Meliá Avenida América, Madrid



Navitas will be exhibiting in upcoming eRegulatory Summit in Madrid which focuses on Connecting rim, IDMP and eCTD professionals to drive regulatory strategies through authority access and industry expertise.

Garry Aldam, Senior Consultant and David Gwyn, Head of Technology Practice at Navitas Life Sciences along with Michael Kline, Senior Solutions Consultant at Sparta Systems, will be speaking on topic “Addressing IDMP Requirements with Navitas and TrackWise – the system you most likely already have.” at 15:50, Apr 25

If you would like further information, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

24
Apr 2017

Webinar hosted by Navitas Networks: PLLR – many questions, some answers

Date: 24 April 2017
Time: 15:30 – 17:00 GMT



We are pleased to announce the next Navitas Networks Webinar is taking place on 24th April and will be presented by Denis Fung (Navitas), Suzette Hildebrand (Pfizer) and Ellen Wong (Allergan)

Agenda:

  • The what and why of PLLR
  • Why PLLR – context and story so far
  • Review of Regulations 1 year on – reflections and impacts
  • A Reflection of different company experiences
  • Pfizer case study
  • Allergan case study
  • Discussion on challenges, lessons learnt and further questions to ponder
  • Forward Look
  • Summary of emerging Best practice
  • Q&A Close
To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

19
Apr 2017

India - TrackWise User Group (TUG)

Date: 19 April 2017
Venue: ITC Maratha, Mumbai
India - TrackWise User Group (TUG)



Navitas and Sparta Systems will host the 3rd TrackWise User Group (TUG) meeting on 19th April 2017 in Mumbai. The event is a platform for TrackWise users across India to connect and share their experiences and best practices. Users can also learn from experts on how to get more from their investments in TrackWise.

If you would like further information, or you would like to register to attend this meeting, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

20
Mar 2017

Oracle Industry Connect Conference 2017

Date: 20 - 22 March 2017
Venue: Orlando, Florida
Oracle Industry Connect Conference 2017



Navitas Multi-Tenant Argus SafetyREADY™ Shared Cloud at Oracle’s Industry Connect Conference
Navitas will be highlighting the SafetyREADY Shared Cloud at the Oracle Industry Connect conference. Traditional deployments of Oracle Argus Safety have meant high implementation, infrastructure and maintenance costs that are prohibitive for many companies. Additionally, Oracle’s case based licensing model means that companies with low case volumes pay for volume that they will not use.

The SafetyREADY™ Shared Cloud utilizes the benefits for multi-tenant cloud sharing, which offers a cost-effective solution (saving more than 50%) for companies with smaller case volumes. Navitas invests in infrastructure and licensing on client’s behalf and reduces implementation costs by utilizing our pre-validated and pre-configured “gold instance”. The flexible costing model adapts to clients changing case volumes over time, clients only pay for what they need.

To learn more, visit Navitas at the Oracle Industry Connect conference in the Life Science pavilion.

If you would like further information, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

16
Mar 2017

pvindia Forum - Spring

Date: 16 March, 2017
Venue: Mumbai, India
pvindia



Following the successful launch of pvindia in 2016, we are delighted to be hosting our third event this year. pvindia, is our network dedicated to bringing together PV Global/Regional Heads of PV and PV Leadership teams in the APAC region.

  • What topics will the forum cover?
  • The latest PV Regulatory context – balancing global and local requirements
  • Update on the global context: FDA, EMA latest PV regulations
  • Deep dive and industry discussion on the proposed PvPI guidelines (building on previous discussion in October)
  • An operational PV perspective, with case studies and discussions
    How to move the community forward

05
Mar 2017

HDA’s 2017 Distribution Management Conference and Expo

Date: 05 – 08 March 2017
Venue: JW Marriott Desert Springs, Palm Desert, California, USA
HDA’s 2017 Distribution Management Conference and Expo



Navitas will be demonstrating traceREADY in booth 108 at HDA’s 2017 Distribution Management Conference and Expo. traceREADY is Navitas’ Edge solution that enables DSCSA compliance. The DSCSA deadline is November 17th, 2017. traceREADY gets up and running quickly and has the lowest total cost of ownership in the marketplace. traceREADY is for Life Science companies that have to comply with DSCSA regulations including pharma/biotech manufacturers, third party logistics (3PL’s) companies and Pre-Manufacturing facilities.

For further information, please visit the event website here or to schedule a demo please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

22
Feb 2017

Webinar hosted by Navitas Networks: E2E labeling – Achieving Global Consistency

Date: 22 February, 2017
Time: 15:30 – 17:00 GMT



Hosted by Navitas Networks this webinar E2E labeling – Achieving Global Consistency will be presented by Tara Baer, one of our expert navigators here at Navitas.

Agenda:

  • The Global labeling Context
  • Trends, drivers, expanding horizons
  • The need for a global approach
  • Building Global connections
  • Labelling – through the eyes of an affiliate / a global perspective
  • The evolving Technology landscape – a global/local E2E view
  • A practical experience
  • Looking forward
  • ​What is on the horizon?

To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

21
Feb 2017

Sidley pvlegal Biannual Meeting

Date: 21-22 February, 2017
Venue: ALK Abelló offices, Hørsholm, Denmark
rimnet



Navitas’ Senior Consultant, Martin Holm-Petersen, will be attending this conference as a delegate.

This interactive meeting will include hot topics in drug and device safety reporting, panel discussions, benchmarking trends, and case studies.

pvlegal is a membership-based forum for in-house counsel and compliance personnel working on pharmacovigilance issues in the Life Sciences sector. This is supported by regular benchmarking of member performance and best practice sharing in the area of drug and device safety reporting. For more information about pvlegal please visit the network website here or contact a member of the pvlegal team at This email address is being protected from spambots. You need JavaScript enabled to view it. or to arrange to meet with Martin please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

08
Feb 2017

DIA’s Regulatory Submissions, Information, and Document Management Forum

Date: 08 - 10 February 2017
Venue: Bethesda, Maryland, USA
rimnet



Navitas will join life science executives from companies such as Amgen, Bristol-Myers Squibb, Pfizer, Teva, and more at DIA’s Regulatory Submissions, Information, and Document Management Forum in Bethesda, Maryland.

For further information please visit the event website here or contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

24
Jan 2017

Navitas and Sparta Systems - EQMS Webinar Series

Date: 24 January 2017
Time: 11:00 am – 12:00 pm IST



1st Webinar of the Series - Ensuring Data Integrity, Mitigating Risk and Quality Metrics

This webinar will address the key challenges life sciences’ manufacturers face and the importance of:

  • Managing quality processes, data and ‘metrics’ consistently and accurately
  • A Quality Management System (QMS) with inherent analytical capabilities:
  • Reduces audit time and findings
  • Decreases risk of product recalls
  • Enables better decisions faster without the high costs of implementing and maintaining an external business intelligence solution

Followed by hands-on live demo of TrackWise Solution.

To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

09
Jan 2017

Sidley Network Events: Inside The Minds of Regulators: Perspectives on Eu Pharmaceutical and Medical Devices Law

Date: 09 January 2017
Venue: The Hotel Brussels, Belguim



Please join us for an inside look at how the latest legal and regulatory developments in EU law will affect companies operating in the life sciences space. We will bring together senior members of the European Commission and regulatory and business community to address the potential impact of new pharmaceutical and medical devices legislation and regulation. Sessions will cover medicinal products, including clinical trials, pharmacovigilance and orphan medicinal products, and medical and in vitro diagnostic devices, as well as competition law issues affecting the pharmaceutical sector. Our panelists/speakers will also discuss the foreseeable impact of Brexit on the life sciences industry.

To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

30
Nov 2016

Webinar Hosted by Navitas Networks: Medical Devices and Combination Products - Safety and Vigilance Requirements in the US and Europe

Date: 30 November, 2016
Time: 15:30-17:00 GMT



Hosted by Navitas Networks this webinar Medical Devices and Combination Products -Safety and Vigilance Requirements in the US and Europe will be presented by Navitas’ Managing Consultant Tido Eger.

Agenda:

  • Introduction 
  • The need for device vigilance in pharma companies
  • FDA’s oversight of combination products, new developments and safety concerns
  • Practical experience with FDA Combination Product rules
  • Questions & Answers 

To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

17
Nov 2016

rimnet Forum

Date: 17 November 2016
Venue: 09:30 – 16:30, New York
rimnet



Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.

Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.

If you are interested in further information or participating at this meeting, please contact a member of our rimnet team at This email address is being protected from spambots. You need JavaScript enabled to view it.

17
Nov 2016

pvconnect Forum

Date: 17 November 2016
Venue: 09:30 – 16:30, New York
labelnet



Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

For further information or to register your interest in participating at this meeting, please contact a member of our pvconnect team at This email address is being protected from spambots. You need JavaScript enabled to view it.

16
Nov 2016

labelnet Forum

Date: 16 November 2016
Venue: 09:30 – 16:3, New York
labelnet



Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

If you are interested in further information or to register your interest in participating, please contact a member of our labelnet team at This email address is being protected from spambots. You need JavaScript enabled to view it.

16
Nov 2016

pvtech Forum

Date: 16 November 2016
Venue: 09:30 – 16:30, New York
pvtech



pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.

If you are interested in further information or participating at this meeting, please contact a member of our pvtech team at This email address is being protected from spambots. You need JavaScript enabled to view it.

15
Nov 2016

Author-It Annual Summit for Life Sciences

Date: 15-16 November 2016
Venue: Hilton Penn’s Landing, 201 S. Columbus Boulevard, Philadelphia, PA, USA
Author-It Annual Summit for Life Sciences



Navitas’ Head of Technology, David Gwyn, will be presenting a session at this conference titled ‘Leveraging Structured Content to Streamline End-to-End Labelling’. This session, taking place on Tuesday 15 November, will discuss a new era of utilising a centralised structured content repository for managing from the CCDS to regional labelling, the integration possible to ‘manage to clock’ necessary in end-to-end tracking, and the interaction with unstructured content

For further information please visit the event website here or to arrange to meet with David please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

15
Nov 2016

pvnet Summit

Date: 15 November 2016
Venue: 09:30 – 16:30, New York
labelnet



Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

For further information or to register your interest in participating at this meeting, please contact a member of our pvnet team at This email address is being protected from spambots. You need JavaScript enabled to view it.

10
Nov 2016

pvnet Summit

Date: 10 November 2016
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
labelnet



Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

For further information or to register your interest in participating at this meeting, please contact a member of our pvnet team at This email address is being protected from spambots. You need JavaScript enabled to view it.

09
Nov 2016

HDA’s (Healthcare Distribution Association) 2016 Traceability Seminar

Date: 09 - 11 November 2016
Venue: Renaissance Washington, DC Downtown Hotel, Washington, DC, USA
Healthcare Distribution Association



Navitas will be demonstrating traceREADY in booth 512 at PackExpo/PharmaExpo November 6-9 in Chicago, IL. traceREADY is Navitas’ Edge solution that enables DSCSA compliance. The DSCSA deadline is November 17th, 2017. traceREADY gets up and running quickly and has the lowest total cost of ownership in the marketplace. traceREADY is for Life Science companies that have to comply with DSCSA regulations including pharma/biotech manufacturers, third party logistics (3PL’s) companies and Pre-Manufacturing facilities.

For further information please visit the event website here or to schedule a demo please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

09
Nov 2016

pvtech Forum

Date: 09 November 2016
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
labelnet



pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.

For further information or to register your interest in participating at this meeting, please contact a member of our pvtech team at This email address is being protected from spambots. You need JavaScript enabled to view it.

09
Nov 2016

labelnet Forum

Date: 09 November 2016
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
labelnet



Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

If you are interested in further information or to register your interest in participating, please contact a member of our labelnet team at This email address is being protected from spambots. You need JavaScript enabled to view it.

08
Nov 2016

rimnet Forum

Date: 08 November 2016
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
labelnet



Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.

Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.

If you are interested in further information or participating at this meeting, please contact a member of our rimnet team at This email address is being protected from spambots. You need JavaScript enabled to view it.

08
Nov 2016

pvconnect Forum

Date: 08 November 2016
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
labelnet



Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

For further information or to register your interest in participating at this meeting, please contact a member of our pvconnect team at This email address is being protected from spambots. You need JavaScript enabled to view it.

06
Nov 2016

PackExpo/PharmaExpo

Date: 06 - 09 November 2016
Venue: McCormick Center, Chicago, IL, USA
PackExpo/PharmaExpo



Navitas will be demonstrating traceREADY in booth 512 at PackExpo/PharmaExpo November 6-9 in Chicago, IL. traceREADY is Navitas’ Edge solution that enables DSCSA compliance. The DSCSA deadline is November 17th, 2017. traceREADY gets up and running quickly and has the lowest total cost of ownership in the marketplace. traceREADY is for Life Science companies that have to comply with DSCSA regulations including pharma/biotech manufacturers, third party logistics (3PL’s) companies and Pre-Manufacturing facilities.

For further information please visit the event website here or to schedule a demo please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

25
Oct 2016

pvindia Forum

Date: 25 October, 2016
Venue: 09:30 – 16:00, The Hyatt Regency Hotel, Mumbai Sahar Airport, Ashok Nagar, Mumbai, Maharashtra 400099, India
pvindia



Following the successful launch of pvindia in March this year, with participation from: Alkem Laboratories, Amgen, Bayer, Boehringer Ingelheim, Colgate Palmolive, Hetero Drugs, Ipca Laboratories, Macleods Pharma, Merck and Co, Mylan, Novo Nordisk, Pfizer, and Wockhardt, we are delighted to be hosting our second event. The agenda will continue to build on the theme of PV Inspection Readiness and will include:

  • The latest PV Regulatory Context – spotlight on the evolving landscape in India
  • The global PV system – balancing global and local requirements
  • The pvindia community moving forward
pvindia leverages the approach, format and experience gained from successfully running pvnetworks over the past 15 years in Europe and the USA. This is a unique opportunity to be part of the industry leading global network for pharmacovigilance professionals

pvindia will provide a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.

For further information please click here
To register your interest in participating, please click here. If you have any further questions then please contact a member of our pvindia team at This email address is being protected from spambots. You need JavaScript enabled to view it.

25
Oct 2016

Nordic Pharmacovigilance Day 2016

Date: 25 October 2016
Venue: Park Inn by Radisson, Copenhagen Airport Hotel, Copenhagen, Denmark
Nordic Pharmacovigilance Day 2016



Navitas’ Head of pvtech and Senior Consultant, Martin Holm-Petersen, is a member of the Scientific Board and will be co-chairing this event.

Navitas’ Managing Consultant, Tido Eger, will be presenting on ‘Integrating medical devices into pharma PV and RA departments’.

For further information please visit the event website at: http://nordicpharmacovigilanceday2016.eventify.it/

19
Oct 2016

Sidley ctlegal Biannual Meeting

Date: 19-20 October 2016
Venue: Helsinn, Lugano, Switzerland
Sidley ctlegal Biannual Meeting



This event will see life sciences peers engaging in topical conversation, learning and networking. This interactive meeting will include hot topics in clinical trials (EU and USA), benchmarking trends, and practical case studies, and industry issues.

Navitas’ Senior Consultant, Janet Fernihough, will be presenting at this meeting on the topic of; ‘Risk Based Monitoring, Personalised Medicine, and Patient Engagement’

Hosted by Sidley Austin LLP, ctlegal is a membership based network for in-house counsel and compliance personnel at pharmaceutical companies working on clinical trial issues in the Life Sciences sector. The network includes regular forums supported by the benchmarking of member performance and best practice sharing in the area of clinical trials.

For further information please visit the network website at: http://ctlegal.navitas.net/ or contact This email address is being protected from spambots. You need JavaScript enabled to view it.

17
Oct 2016

Navitas Networks IDMP – Getting Ready webinar

Date: 17 October, 2016
Time: 15:30 – 17:00 British Summer Time
Navitas Networks IDMP - Getting Ready webinar



Hosted by Navitas Networks this webinar will be presented by Navitas’ Senior Consultant Gary Aldam.

The webinar will address the following:

  • The evolving IDMP regulatory landscape
  • How does industry prepare?
  • A working group perspective
  • A range of approaches
  • Getting Ready for IDMP
  • Roadmap for success, with real industry examples
  • Success strategies and lessons learnt
  • Looking forward
  • Ready or not, how success will be measured
  • Close and next steps

To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

05
Oct 2016

DIA 10th European Forum for Qualified Person for Pharmacovigilance (QPPV)

Date: 05-06 October 2016
Venue: The Crystal, London, UK
DIA 10th European Forum for Qualified Person for Pharmacovigilance (QPPV)



Now in its tenth year, the DIA European Forum for QPPV will look to meet the following objectives:

  • Hear the latest updates and hot topics relating to the role of the QPPV
  • Explore long term PV visions, future directions of the ‘PV world’, and potential impact on the role of QPPV
  • Network with colleagues and meet regulators
  • Learn from and share experience and ideas with like-minded QPPVs in a neutral environment
  • Take away practical hints and tips
  • Better understand regulatory and inspectorate expectations of the QPPV
  • Identify the expanded expectations of the role in the context of the new regulatory framework and transparency initiatives
  • Examine current areas of real challenge

Navitas’ Principal Consultant, Jeff Ho, will be presenting a poster presentation at this meeting titled ‘Efficient Content Management for the compilation and management of the PSMF’. This poster will evaluate the potential opportunities for efficient management of content utilised in the compilation and management of the PV System Master File.

To view the event programme, please click here

To arrange to meet with Jeff Ho, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

22
Sep 2016

Navitas Networks and AbbVie webinar PV Organisations Reimagined - Roadmap to transforming into a strategic PV organisation

Date: 22 September 2016
Time: 15:30 – 17:00 British Summer Time



Hosted by Navitas Networks and AbbVie, this webinar will be presented by Navitas’ Principal Consultant, Wilfred Gilich and, from AbbVie, Dr. Linda Scarazzini, Vice President PV and Patient Safety, Jenifer Koeller, Senior Director Business Solutions PV and Patient Safety, and Kemi Yusuf, Director Business Solutions Project Management PV and Patient Safety. The webinar will address the following:

  • The rapidly changing landscape for PV organisations
  • How PV organisations must respond
  • Anatomy of a strategic PV organisation
  • A case study from AbbVie
  • Roadmap to defining the PPS (Pharmacovigilance and Patient Safety) 2020 vision
  • Bringing PPS 2020 to life
  • Impact and results…so far
  • What lies ahead?
  • Key learnings for other PV organisations
  • Looking forward

To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

22
Sep 2016

Sparta Systems and Navitas Webinar: Addressing IDMP System Requirements with TrackWise

Date: 22 September 2016
Time: 11:00 ET



This webinar will provide an overview of the FDA Guidance for the recent IDMP regulation and explain how pharmaceutical companies should prepare and build a solution to meet the IDMP specifications that are connected to the TrackWise system.

Presenters
  • Scott Mitreuter, Product Management at Sparta Systems
  • David Gwyn, Head of Technology at Navitas, Inc.
Areas covered in the webinar
  • FDA and ISO requirements for IDMP
  • Establishment of an IDMP strategy
  • Develop a solution to meet the new IDMP guidelines
  • Integration between Sparta Systems’ TrackWise and Navitas

This webinar will provide insight for pharmaceutical companies on building a strong solution to meet the regulatory requirements of IDMP. To register your attendance please visit the event website here.

17
Sep 2016

RAPS 2016 Regulatory Convergence

Date: 17-20 September 2016
Venue: San Jose, California
RAPS 2016 Regulatory Convergence



Navitas will be highlighting regulatory solutions at the Regulatory Affairs Professionals Society annual meeting. IDMP is a popular topic with regulatory professionals and Navitas will showcase IDMP best practices along with idmpREADY Navitas will also provide attendees with case studies and demos of pharmaREADY, the end – to – end regulatory software suite, which is comprised of eCTD, Document Management, Structured Product Label Management, Training Records Management and Paper Submissions modules.

Navitas will also talk about regulatory submissions and publishing services. Navitas provides submission and publishing services for leading life science companies throughout the world and has regulatory operations hubs in India and Colombia.

If you would like further information, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

12
Sep 2016

DIA Global Labeling 2016

Date: 12 -13 September 2016
Venue: Omni Shoreham Hotel, Washington DC, USA
DIA Global Labeling 2016



The DIA Global Labeling 2016 conference has been developed in collaboration with the Regulatory Affairs Community Labeling Working Group and will address the following topics:

  • Global Labeling issues and updates
  • Labeling role
  • Pharmacovigilance Risk Assessment
  • Packaging issues
  • Combination products
  • Biosimilars
  • Patient leaflet
  • Plain language labeling
  • Patient Medication Information (PMI)
  • International Strategic Plan
Navitas’ Senior Managing Consultant, Tara Baer, will be presenting at this conference on the topic of; ‘EU Issues; particularly looking at labeling for a combined medicinal product and medical device’. This is part of Session 3: Labeling for Combination Products and Devices taking place on Monday 12 September between 14:00 and 15:00.

For further information please visit the DIA event website here or to arrange to meet with Tara please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

07
Sep 2016

Navitas’ pvindia Webcast: Getting Inspection Ready

Date: 07 September 2016
Venue: 14:00 – 15:30 IST
pvindia



Hosted by Navitas’ pvindia Network, and presented by Louise Jebson, Head of Networks at Navitas Life Sciences and Jean-Christophe Delumeau, Head of Pharmacovigilance China and Asia Pacific at Bayer HealthCare, this webcast will explore the topic of ‘Getting Inspection Ready’. Staying abreast of what regulatory authorities require can be difficult to achieve. Success or failure of an inspection from a regulatory authority is determined by both practice and preparation. This webinar highlights the obstacles and pitfalls, strategy design, together with making inspection management a priority.

  • Latest Regulatory Context
  • Global trends and context
  • Emerging Indian regulations
  • A case study approach to Audits and Inspections -  Bayer HealthCare
  • 5 Steps to Inspection Readiness
  • An integrated approach and mindset
  • PSMF – core and local
  • Governance and roles
  • Compliance metrics and KPIs
  • Managing CAPAs
  • Where next?
To register to attend this webcast, please click here or for further information please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

This webcast is hosted by Navitas’ pvindia Network; to find out more about pvindia please click here.

29
Aug 2016

CPhI’s Unannounced Audits Workshop

Date: 29-30 August 2016
Venue: The Westin Mumbai Garden City, Mumbai
CPhI’s Unannounced Audits Workshop



Navitas along with Sparta Systems is exhibiting at CPhI’s Unannounced Audits Workshop, which guarantees routine success in FDA inspections which would integrate company culture built on sustaining compliance, significant training and preparation, and flawless execution during the inspections. One can learn from leading USFDA pharma experts on managing audits in complex environments. Mohan Ponnudurai of Sparta Systems will be presenting on audit capabilities of TrackWise including risk assessments and compliance.

Visit our stand to know more about Navitas’ proprietary implementation framework – qualityREADY, designed to deploy TrackWise EQMS Application for your organization. This framework accelerates TrackWise implementations, reduces risks and lowers costs, brings industry best practices to business processes and provides flexibility to allow key configurations while ensuring audit readiness.

If you would like further information, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

06
Jul 2016

Next Generation PV Tools’ webcast

Date: 06 July 2016
Time: 15:30 – 17:00 British Summer Time



Hosted by Navitas Networks, this webcast will be presented by Navitas’ Senior Consultant, Martin Holm-Petersen. The webcast will address the following:

  • IT as the game changer
  • Exploring macro-trends that are changing the technological landscape for Pharma
  • Technology drivers that are changing how we do PV
  • What does digitally transformed PV look like?
  • Automation, new sources of data, machine learning, and unstructured text analysis, generation of insights
  • Building IT strategies for PV
  • Drivers and challenges
  • Cross portfolio strategies
  • Roadmap for success

To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

26
Jun 2016

DIA 2016 52nd Annual Meeting

Date: 26 -30 June 2016
Venue: Pennsylvania Convention Center, Philadelphia, USA
DIA




Navitas is delighted to have three of our Expert Navigators presenting at the DIA’s 52nd Annual Meeting.

Tuesday 28 June, 2016 10:30 – 11:45

Navitas’ Managing Consultant, Hershell Thompson, will be chairing the session ‘The Global Conundrum: Herding Cats – Identifying Risk across Pharmacovigilance networks and seeking simplicity in multi-country Pharmacovigilance activities’

For further information please click here

Tuesday 28 June, 2016 16:00 – 17:15

Navitas’ Principal Consultant, Denis Fung, will be speaking as part of the ‘Improving Adverse Drug Reaction Information in Product Labels’ session

For further information please click here

Navitas will also be presenting a poster titled “End – to – End Change Control: An Integral Approach to Product Changes, Submissions and Variation Management”, which explains the basic concepts of End – to – End change control and provides key insights into the key benefits and challenges relating to End – to – End change control.

If you would like to arrange to meet with a member of our team at the DIA event then please do get in touch at This email address is being protected from spambots. You need JavaScript enabled to view it.

23
Jun 2016

pvconnect Forum

Date: 23 June 2016
Venue: London
labelnet



Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts. For further information or to register your interest in participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

22
Jun 2016

pvtech Forum

Date: 22 June 2016
Venue: London
labelnet



pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.

For further information or to register your interest in participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

21
Jun 2016

pvnet Summit

Date: 21 June 2016
Venue: London
labelnet



Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts. For further information or to register your interest in participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

16
Jun 2016

pvconnect Forum

Date: 16 June 2016
Venue: New York
labelnet



Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts. For further information or to register your interest in participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

15
Jun 2016

labelnet Forum

Date: 15 - 16 June 2016
Venue: New York
labelnet



Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

If you are interested in further information or to register your interest in participating, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

15
Jun 2016

pvtech Forum

Date: 15 June 2016
Venue: New York
labelnet



pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

14
Jun 2016

rimnet Forum

Date: 14 June 2016
Venue: New York
labelnet



Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held in October, 2014 and May and June, 2015, again in both locations.

Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

14
Jun 2016

pvnet Summit

Date: 14 June 2016
Venue: New York
labelnet



Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

26
May 2016

Navitas - Oracle Webinar Series: Oracle Argus Implementations migrations, upgrades & maintenance
5th last webinar of this series - Application Management Services

Date: 26 May 2016
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)



Navitas’ Application Management Services (AMS) allow you to get the most out of your IT investments by reducing your cost of management and support, whilst increasing customer satisfaction and quality of service. This webinar will talk you through the Navitas application lifecycle approach.

Register Now!

25
May 2016

7th Outsourcing in Clinical Trials East Coast 2016

Date: 25 - 26 May 2016
Venue: King of Prussia, Pennsylvania
 7th Outsourcing in Clinical Trials East Coast 2016



Georgina Wood, Navitas’ Clinical Data Solutions Practice Lead, will speak at the 7th Annual Outsourcing in Clinical Trials East Coast conference May 25th & 26th in King of Prussia, Pennsylvania. According to research, the clinical outsourcing market will increase from $38 Billion to $64 Billion by 2020. The vendor selection process is time consuming, costly and often based on subjective criteria rather than on objective analysis. Ms. Wood will outline how companies can utilize industry best practices to improve their vendor selection process as well as improving their bottom line.

23
May 2016

Navitas Highlights Quality and IDMP at Sparta Connection Orlando

Date: 23 - 26 May 2016
Venue: JW Marriott Grande Lakes, Orlando, Florida
Sparta Connection



Navitas is a platinum sponsor at the Sparta Connection conference in Orlando, Florida May 23-26. Sparta Connection attendees will gain insights into how game-changing technology and strategies in mobile, SaaS and business analytics are propelling companies to new heights. Navitas will be highlighting qualityREADY®, which accelerates TrackWise implementations, reduces risks and lowers costs, brings industry best practices to business processes and provides flexibility to allow key configurations while ensuring audit readiness. Also highlighted will be idmpREADY®. idmpREADY is Navitas’ technology solution that enables life science companies to comply with coming regulations in Europe and throughout the world.

25
May 2016

rimnet Forum

Date: 25 May 2016
Venue: Sidley Austin LLP offices in London
labelnet



Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held in October, 2014 and May and June, 2015, again in both locations.

Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

24
May 2016

labelnet Forum

Date: 24 May 2016
Venue: Sidley Austin LLP offices in London
labelnet



Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

If you are interested in further information or to register your interest in participating, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

11
May 2016

Navitas - Oracle Webinar Series: Oracle Argus Implementations migrations, upgrades & maintenance
4th webinar of this series - Increase your upgrades to reduce your cost and complexity

Date: 11 May 2016
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)



Navitas in partnership with Oracle is pleased to invite you to a series of Oracle Argus webinars. Whether you are considering an Oracle Argus implementation, looking to upgrade your existing system or want to consider your options for system maintenance, these webinars are for you. In this webinar we will talk you through Navitas’ forward thinking approach to system upgrades.

Register Now!

28
Apr 2016

Navitas - Oracle Webinar Series: Oracle Argus Implementations migrations, upgrades & maintenance
3rd webinar of this series - Data Migration

Date: 28 April 2016
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)



Navitas in partnership with Oracle is pleased to invite you to a series of Oracle Argus webinars. Whether you are considering an Oracle Argus implementation, looking to upgrade your existing system or want to consider your options for system maintenance, these webinars are for you. Migrating legacy safety applications can be a daunting task due to the complexities involved. Navitas has prebuilt migration packages that enable rapid, compliant migrations from legacy applications (as well as Excel spreadsheets) to help smooth your implementation and provide peace of mind.

Register Now!

26
Apr 2016

2016 Blue User Conference

Date: 26 April 2016
Venue: Chicago Athletic Association Hotel, Chicago, IL



Tara Baer from Navitas speaks at the 2016 Blue User Conference. Tara Baer, labeling expert from Navitas, will present “Breaking Down the Walls for a Better Process” on April 26th at 8:45 a.m.

Tara is an experienced leader in Medical Device and Pharmaceutical labeling. She has worked at such industry leaders as AbbVie, Boston Scientific, Wyeth and Intervet, where she developed a passion for End-to-End Labeling Management, from safety through distribution. An experienced manager, guide and motivator, she has led diverse teams of professionals towards collaborative solutions. Tara has a proven record of accomplishment of successfully delivering projects with aggressive timelines and budgets, with a focus on risk and quality management. She specializes in translation management, workflow, content development, automated tracking/process integration, and asset management.

21
Apr 2016

CPhI’s CAPA & Root Cause Investigation Workshop

Date: 21 - 22 April 2016
Venue: Meluha The Fern, Mumbai, India
CPhI’s CAPA & Root Cause Investigation Workshop



Navitas along with Sparta Systems is exhibiting at CPhI’s CAPA & Root Cause Investigation Workshop, which is the only forum in India dedicated to identifying non-compliance, understanding the root cause, and responding with appropriate corrective and preventive actions for the Pharmaceutical companies. Mohan Ponnudurai of Sparta Systems is a speaker at this event.

Visit our stand to know more about Navitas’ proprietary implementation framework – qualityREADY, designed to deploy TrackWise EQMS Application for your organization. This framework ensures high quality regulatory compliant deployment within a short timeframe. This framework comprises of accelerators for Process Design, Configuration, Validation, Data Migration and Training.

If you would like further information, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

20
Apr 2016

Navitas - Oracle Webinar Series: Oracle Argus Implementations migrations, upgrades & maintenance
2nd webinar of this series - Accelerated Oracle Argus Implementations

Date: 20 April 2016
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)



Navitas in partnership with Oracle is pleased to invite you to a series of Oracle Argus webinars. Whether you are considering an Oracle Argus implementation, looking to upgrade your existing system or want to consider your options for system maintenance, these webinars are for you. This webinar will explain how our accelerators can fast track your Oracle Argus implementation whilst ensuring it is tailored to your specific business requirements.

Register Now!

20
Apr 2016

India - TrackWise User Group (TUG)

Date: 20 April 2016
Venue: Hyatt Regency, Mumbai
India - TrackWise User Group (TUG)



Navitas and Sparta Systems will host the 2nd TrackWise User Group (TUG) meeting on 20th April 2016 at the Hyatt Regency, Mumbai. The event is a platform for TrackWise users across India to connect and share their experiences and best practices. Users can also learn from experts on how to get more from their investments in TrackWise.

If you would like further information, or you would like to register to attend this meeting, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

14
Apr 2016

Labelling End-to-End Tracking Tools in Action Webcast

Date: 14 April 2016
Time: 15:30 – 17:00 BST



Hosted by Navitas Networks, this webcast will be presented by David Gwyn, Head Technology Practice at Navitas Life Sciences, Inc. and Craig Trautman, CEO, Intagras. The webcast will address the following:

  • A reminder of why E2E tracking is key
  • The start and end point of labelling
  • Tracking tools in action
  • Looking forward

To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

13
Apr 2016

The Digital Transformation in Pharma

Date: 13 - 14 April 2016
Venue: Tivoli Hotel and Congress Center, Copenhagen, Denmark
The Digital Transformation in Pharma



Navitas’ Senior Consultant, Martin Holm-Petersen, will be presenting a session titled ‘Realigning pharma – patient data driven scenarios’ on Wednesday 13 April from 11:00 – 11:45. This session will explore how pharma companies are looking for future opportunities emerging from new data sources. It will explore scenarios as well as a case study for bringing patient/consumers closer to the business via mHealth and personal health records. The session will also discuss:

  • How real-world evidence will integrate in the pharma value chain
  • How it will impact the pharma business operating model and cause internal realignment within organisations
06
Apr 2016

Navitas - Oracle Webinar series: Oracle Argus Implementations, migrations, upgrades and maintenance

Date: 06 April 2016
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)



Navitas in partnership with Oracle is pleased to invite you to a series of Oracle Argus webinars. Whether you are considering an Oracle Argus implementation, looking to upgrade your existing system or want to consider your options for system maintenance, these webinars are for you.

First of the series is Oracle Argus in the Cloud. This webinar will talk you through the advantages of cloud implementations, our expedited approach to implementation and the options open to you.

Register Now!

31
Mar 2016

IDMP - From Concept to Reality Webcast

Date: 31 March 2016
Time: 15:30 – 17:00 BST



Hosted by Navitas Networks, this webcast will be presented by Rens van den Boomen, Managing Consultant at Navitas Life Sciences and will address the following:

  • Latest Regulatory context for IDMP
  • IDMP – 5 steps to success
  • Maturity Assessment
  • Strategy Roadmap
  • Program Management
  • System Implementation
  • IDMP Deployment
  • Where next?
To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

22
Mar 2016

5th Annual Clinical Data Integration and Management 2016

Date: 22 March 2016
Venue: Princeton, New Jersey
5th Annual clinical data integration and management



Georgina Wood, Clinical Data Practice Leader for Navitas, will present “Clinical Data Integration – Integral to Risk Based Monitoring, Quality based payments and SDTM like outputs” at the 5th Annual Clinical Data Integration & Management conference Tuesday, March 22nd in Princeton, New Jersey.

Her session will discuss how to establish next generation clinical analytics by incorporating a robust clinical data integration platform as an essential and pre-requisite foundational architectural component. Realizing differences in scope and complexity of integration across enterprises by adopting SaaS based data collection and clinical trials management systems will be explored. Also covered will be:

  • Analyzing a custom development of a data warehouse with scope of integrating data from output for operational and bio-statistical programing needs
  • Discussing a SaaS based integration platform with the scope of integration across all systems enabling adaptive monitoring (RBM with Central and Medical Monitoring)

This session will take place at 11:30 on Tuesday, March 22nd.

17
Mar 2016

Pharmacovigilance 2016

Date: 17 March 2016
Venue: DGI-byen Conference Centre, Copenhagen, Denmark
Pharmacovigilance 2016



Navitas’ Senior Consultant, Martin Holm-Petersen, will be part of an expert panel discussion on PASS and PAES designs at this event. The session will explore:

  • Secondary use of health data
  • Use of big data sources in PV – how far are we?
  • Data driven pharmacovigilance and elaborate post authorisation monitoring of benefit-risk in the market has been conceptualised, but how far are we in the industry?
  • Industry perspectives – a hot topic

For further information please visit the event website at: http://insightevents.dk/events/pharmacovigilance-2016/

06
Mar 2016
Date: 06 - 09 March 2016
Venue: JW Marriott San Antonio Hill Country, San Antonio, Texas
HDMA



Navitas will be highlighting its traceREADY Warehouse Edge System at the HDMA Conference. HDMA is the national association representing primary healthcare distributors, the link between the nation’s pharmaceutical manufacturers and healthcare providers.

Navitas’ traceREADY Warehouse Edge System enables the capture of serialized warehouse transactions which regulations mandate the recording of all business events in a centralized repository for enabling Track and Trace for supply chain security.

In order to ensure accurate and timely data from the packaging line, it is necessary to have an application to collect the required data and transfer the same to the central repository.

traceREADY automates warehouse / manufacturing transactions, meets validation requirements and complies with GxP norms, supports multiple form factors on Windows, Android and iOS devices and enables online and offline mobile transactions. traceREADY was designed to be a highly configurable and scalable architecture and integrates seamlessly with ERP (SAP, Oracle, JDE) and EPCIS repositories.

To learn more or to view a demo, visit Navitas in booth 112 at the HDMA conference.

03
Mar 2016

pvindia Forum

Date: 03 March 2016
Venue: Mumbai, India
pvindia



Navitas is delighted to announce that we will soon be adding to our portfolio of industry leading networks with the launch of pvindia; a network for Heads of Safety of Indian life sciences companies with pharma, consumer, generics, or mixed portfolios.

pvindia will leverage the approach, format and experience gained from successfully running pvnetworks over the past 14 years in Europe and the USA. This is a unique opportunity to be part of the industry leading global network for pharmacovigilance professionals.

pvindia will provide a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues. For further information please click here to register your interest in participating, please contact a member of our networks team at This email address is being protected from spambots. You need JavaScript enabled to view it.

24
Feb 2016

Pharma Packaging and Labeling USA 2016

Date: 24 – 25 February 2016
Venue: Philadelphia, USA
labelnet



Navitas Speaking at the Pharma Packaging and Labeling USA 2016.

Navitas will present innovative packaging and labelling strategies and tactics at the Pharma Packaging and Labeling USA 2016 conference. David Gwyn, Navitas’ technology practice leader, will discuss models for success for effective labelling that aligns across functions to deliver a compliant, label management process.

18
Feb 2016

Global PV Connections - Managing across borders Webcast

Date: 18 February 2016
Venue: 15:30 – 17:00 GMT



Hosted by Navitas Networks, this webcast will be presented in three sections and will address the following:
Presented by Jeffrey Ho, Principal, Navitas Life Sciences

  • Building global connections
  • Managing across borders - affiliates and partners
  • Assessing risk and resource needs
  • Strategies for success

Speaker to be confirmed

  • The shifting global PV context
  • Shifting regulations and a complex landscape
  • Rising volumes and headcount squeeze

Presented by Lesia Tontisakis, Director of PV, Allergan

  • Case Study: Developing an improvement plan; preventing pitfalls and realising benefits
To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it..
04
Feb 2016

ECCRT Seminar: Outsourcing models in Clinical R&D

Date: 04 February 2016
Venue: Pullman Hotel - Place Victor Horta 1 - 1060 Brussels
ECCRT



Navitas’ Shalabh Kumar to speak at the European Centre for Clinical Research Training

Shalabh Kumar, Navitas’ Global Head of Outsourcing Services, will speak at the February 4th European Centre for Clinical Research Training seminar at the Pullman Hotel in Brussels. Mr. Kumar, along with Eric Chleide and David Baugnies of GSK Vaccines, will explore the benefits and possible pitfalls of Clinical R’D outsourcing models.

09
Dec 2015

Safety Requirements for Medical Devices and Combination Products

Date: 09 December 2015
Venue: 15:30 – 17:00 GMT



Hosted by Navitas Networks, this webcast will be presented in three sections and will address the following:

Presented by Tido Eger, Navitas

  • Safety drivers for pharmaceutical companies in the medical device space
  • The differences between drug and device requirements, including drug vs. device reporting
  • The challenges for pharmaceutical companies around Safety reporting for devices and CP
  • The view and solutions from Navitas
Presented by Maurits Lugard, Sidley Austin LLP
  • Current safety requirements – focus on vigilance reporting
  • Enforcement landscape and expectations of authorities and notified bodies
  • Medical Devices and IVD Regulations – thoughts on new safety requirements
Presented by Dan Zenker, Navitas
  • Case study: what we are seeing in industry, our approach, solution, and challenges

To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

02
Dec 2015

rimnet Forum

Date: 02 December 2015
Venue: Sidley Austin LLP offices in London
RIMnet



Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York City and London. The positive feedback from the participants, and the need for further discussion led to a second roundtable being held in fall 2015, again in both locations.

Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

17
Nov 2015

IDMP Readiness Revisited Webcast

Date: 17 November 2015
Venue: 15:30 – 17:00 (GMT)



Owing to the popularity of this webcast back in October, we will be re-running the session.

Hosted by Navitas Networks, this webcast will explore IDMP Readiness and address the following:

  • Latest update on regulatory context for IDMP
  • Real-time IDMP examples – the challenges our clients are facing
  • IDMP readiness – what good looks like
  • Where next?
To register to attend this webcast, please click here or for further information please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

11
Nov 2015

rimnet Forum

Date: 11 November 2015
Venue: Sidley Austin LLP offices in New York
RIMnet



Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York City and London. The positive feedback from the participants, and the need for further discussion led to a second roundtable being held in fall 2015, again in both locations.

MMoving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

11
Nov 2015

pvtech Forum

Date: 11 November 2015
Venue: Sidley Austin LLP offices in New York
pvtech



pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

11
Nov 2015

pvconnect Forum

Date: 11 November 2015
Venue: Sidley Austin LLP offices in New York
pvconnect



Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

10
Nov 2015

pvnet Summit

Date: 10 November 2015
Venue: Sidley Austin LLP offices in New York
pvnet



Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

05
Nov 2015
Date: 05 November 2015
Venue: 11 AM EST



Legal Contract Management – control your contracts by leveraging the power of metadata. Review a dashboard of upcoming contract renewals, determine the value of what is ahead combined with the workload and the resources needed. Witness what is possible through a next-generation user experience in an environment where simple solutions are often the most useful. Take control of your contracts instead of them controlling you.

Register Now!

05
Nov 2015

pvconnect Forum

Date: 05 November 2015
Venue: Sidley Austin LLP offices in London
pvconnect



Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

05
Nov 2015

pvtech Forum

Date: 05 November 2015
Venue: Sidley Austin LLP offices in London
pvtech



pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

04
Nov 2015
Date: 04 November 2015
Venue: 11 AM EST



Human Resource Management – integrate the management of offer letters, personnel files and other critical HR documents in the same platform you use for the rest of your business. Provide automated review and approval processes both in the office and through mobile devices and avoid manual paper processing. Take your HR environment to the next generation while leveraging your current content management investment.

Register Now!

03
Nov 2015

pvnet Summit

Date: 03 November 2015
Venue: Sidley Austin LLP offices in London
pvnet



Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

29
Oct 2015
Date: 29-30 October 2015
Venue: The Westin, Mumbai, India
cmonet



Navitas is participating along with Sparta Systems in this workshop that brings you a two-day Data Integrity, Reliability & Quality Metrics. The workshop focuses on the issues related data integrity, reliability and also on quality metrics and pilot programs in the US. Experts from Lachman Consultants will be conducting the Workshop.

29
Oct 2015
Date: 29 October 2015
Venue: 11 AM EST



Quality – manage you standard operating procedures (SOP), work instructions, specifications, analytical methods and other quality-related documents in a sip le yet powerful user interface. Manage the lifecycle of the documents from draft through effective and control where documents are printed and who can access copies and at what status. Witness the simple power of scanning a QR code to retrieve the current SOP on the shop floor with your handheld device. Experience simple, innovative and controlled quality document management.

Register Now!

24
Oct 2015
Date: 24-28 October 2015
Venue: Baltimore, Maryland
RAPS



Navitas will be highlighting regulatory operations outsourcing solutions, along with eCTD software, at the Regulatory Affairs Professional Society (RAPS) annual meeting. The solutions highlighted will include Submissions & Report Publishing, License Maintenance, Labeling & Artwork Services, Regulatory Information Management and Regulatory Strategy & Support. Additionally, pharmaReady®, Navitas’ suite of fully integrated regulatory document management system, from document creation through regulatory submissions, will be demonstrated.

27
Oct 2015
Date: 27 October 2015
Venue: 11 AM EST



Correspondence Management – track communications more effectively by collating all information together in a single entity in your repository. Witness the integration of emails with attachments from a regulatory authority being stored as combined PDF document, complete with a forms-based manifestation of all critical metadata about the correspondence. Reduce your stress level when tracking and responding to health authorities with the next-generation user experience.

Register Now!

22
Oct 2015
Date: 22 October 2015
Venue: 11 AM EST



Mobile Access – experience content management 21st century where key decision makers can review and approve documents securely from their mobile devices. Watch a live demonstration showing interaction between a user on their computers and a user on their mobile phone. See how efficient it can be to work remotely using a custom-built application instead of a mobile browser, logging in with a scan of a thumbprint and signing a document without putting a pen to paper.

Register Now!

21
Oct 2015
Date: 21 October 2015
Venue: 15:30 – 17:00 (British Summer Time)



Hosted by Navitas Networks, this webcast will explore IDMP Readiness and address the following:

  • Latest update on regulatory context for IDMP
  • Real-time IDMP examples – the challenges our clients are facing
  • IDMP readiness – what good looks like
  • Where next?
To register to attend this webcast, please click here or for further information please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

Most Marketing Authorisation Holders, as well as Contract Manufacturing Organisations, are starting to prepare for IDMP. A global compliance requirement that will become legally enforceable by the EMA from the middle of 2016 onwards.

During the summer period, the EMA IDMP Taskforce has given an insight to the approach they are proposing to the European Commission to follow. Although timelines are more realistic, the amount of effort involved, associated budgets required, and resources to plan for over the years to come, are still very substantial.

There is no doubt, from an objective perspective, that what IDMP proposes makes good sense. However, what we have seen so far within our client engagements, is that the transition to IDMP raises a lot of challenges, both technological as well as organisational.

There are many elements to IDMP that organisations need to consider, compliance to the EMA, although important, is just one of them. In order for global organisations to ensure that a truly long-term sustainable solution is in place they must think of IDMP holistically.

Click here to view our latest thoughts on IDMP.

20
Oct 2015
Date: 20 October 2015
Venue: 11 AM EST



Electronic Trial Master File (eTMF) – learn how to manage your TMF electronically, reducing your dependence on paper files while maintaining a compliant repository. See how you can scale this platform by selectively opening access to external partners and providing a user experience that Principal Investigators and Clinical Research Assistants can use without training. Experience an integrated solution that connects with your regulatory submission platform to enable sharing of documents and eliminating duplicates and mistakes.

Register Now!

14
Oct 2015
Date: 14-16 October 2015
Venue: Renaissance Arlington Capital View Hotel, Arlington, Va.
cmonet



Navitas is proud sponsor at this prestigious conference that provides details on the key requirements for implementation of the DSCSA, with a legislative and regulatory review and insights into state requirements and pre-emption.

09
Oct 2015
Date: 09-10 October 2015
Venue: Hotel Sofitel, Bandra East, Mumbai, India
cmonet



The 18th Indian Drug Manufacturers APA Pharmaceutical Analysts’ Convention is themed around ‘Quality and Compliance – Global Expectations’. The convention will look at global requirements in the field of Quality Management and Regulatory Compliance and address the issues and challenges facing the industry.

On Friday 09 October, Navitas CEO, Jim Tizzard will address delegates with a session titled ‘Quality and Compliance, Reputation and Leadership’. In addition, Navitas’ Head of Operations, Marty Boom, will present a session titled ‘‘Integrating to the global QMS – best practices’

For further information about the event, please visit the IDMA website here

08
Oct 2015
Date: 08 - 10 October 2015
Venue: Country Inn & Suites By Carlson, Mysore, Karnataka India
cmonet



Navitas is proud sponsor at this prestigious conference that encourages statistical programmers from the healthcare industry to convene, and provides a platform to share novel ideas in statistical programming, network and strengthen statistical programming community in India.

06
Oct 2015
Date: 06 October 2015
Venue: Copenhagen Park Inn by Radisson, Copenhagen Airport Hotel, Denmark
nordic pharmacovigilance day



Navitas’ Principal Consultant, Jeffrey Ho, and Senior Consultant, Martin Holm-Petersen, will both be speaking at the Nordic Pharmacovigilance Day 2015.

Martin Holm-Petersen is a member of the Scientific Board and will co-chair the event with Anne Gramkow, Head of Drug Safety and QPPV at Pharmacosmos. The event will share best practices, results, and experiences within the field of Pharmacovigilance.

Navitas’ Jeffrey Ho will present a session on Affiliate PV Risk.

Further information can be found on the event website here.

26
Aug 2015

TAKE Academy of Life Sciences and Leadership One day Workshop: Regulatory Compliance with Current Challenges

Date: 26 August 2015
Venue: 09:00 – 17:30, Taj Krishna, Hyderabad, India



Navitas’ Principal Consultant, Oliver Steck will be speaking at this one day workshop focusing on Regulatory Compliance with Current Challenges

The workshop will address:

  • Challenges relating to PDUFA fees
  • Process development
  • Technology transfer
  • Exhibit batches
  • Data generation
  • Stability data

This workshop will provide valuable insights through case studies and methodologies, to all sterile and non-sterile pharma and biotechnology industries. The program is aimed at:

  • CEOs
  • Directors
  • VPs
  • GMs
  • Senior Managers

Further information and details of how to register can be found on the event website here

25
Aug 2015

TAKE Academy of Life Sciences and Leadership One day Workshop: Regulatory Compliance with Current Challenges

Date: 25 August 2015
Venue: 09:00 – 17:30, Taj West End, Bangalore, India



Navitas’ Principal Consultant, Oliver Steck will be speaking at this one day workshop focusing on Regulatory Compliance with Current Challenges

The workshop will address:

  • Challenges relating to PDUFA fees
  • Process development
  • Technology transfer
  • Exhibit batches
  • Data generation
  • Stability data

This workshop will provide valuable insights through case studies and methodologies, to all sterile and non-sterile pharma and biotechnology industries. The program is aimed at:

  • CEOs
  • Directors
  • VPs
  • GMs
  • Senior Managers

Further information and details of how to register can be found on the event website here

19
Aug 2015

Webinar: EDM Submission Reference Model - Shaping how submission content is managed

Date: 19 August 2015
Venue: 10:00–11:00 Eastern Time



Navitas’ content management practice lead, David Gwyn, will be speaking on the EDM Reference Model. IRISS is recognized as a pharmaceutical industry trade organization, which provides a mechanism for IRISS (Implementation of Regulatory Submission Standards) to collaborate with other trade organizations within the pharmaceutical industry (i.e. PhRMA, DIA, RAPS, HL7) as well as global health authorities.

Mr. Gwyn’s presentation “EDM Submission Reference Model - Shaping how Submission Content is Managed” will showcase the output of DIA’s (Drug Information Association) EDM Submission Reference Model team and present the background of how the model was created, where it is today and the future roadmap of development. The session will conclude with information on how to obtain the model and how to participate in future activities. The topic and content are the output of DIA’s (Drug Information Association) EDM Submission Reference Model team that Mr. Gwyn led.

Register Now!

27
Jul 2015

5th Annual Medical Device Global Regulatory Intelligence Conference

Date: 27 - 28 July 2015
Venue: Alexandria, Virginia
pvnet



Mayank Raizada will be presenting ‘Regulatory Aspects and Practical Considerations for Combination Product Surveillance’. Mayank’s session will explore the impact of regulations for managing Combination Products on safety surveillance and product quality while providing an understanding on how the variability in combination product regulations is forcing companies to re-evaluate the functioning to ensure compliance and maintain efficiency.

The talk will also provide attendees the building blocks for setting up a compliant and efficient process for managing combination product surveillance, highlighting how governance can be the glue that binds Process, Organization, and Compliance together where functional ownership fails.

01
Jul 2015

End-to-End Labelling webinar

Date: 01 July, 2015

Time: 16:30 – 18:00 Central European Time
15:30 – 17:00 British Summer Time
10:30 – 12:00 Eastern Daylight Time
Navitas are excited to announce the third webinar in our series, focusing on the topic of End-to-End (E2E) Labelling.

Label management is a complex activity that is on-going throughout the lifecycle of a pharmaceutical product. Effective labelling, from label creation and updates through to implementation, is a truly cross-functional process which spans across Pharmacovigilance, Regulatory Affairs, Medical Affairs, and Supply Chain. The need to have E2E labelling oversight is now a regulatory expectation and no longer just a future requirements. E2E tracking of status and timelines is an essential part of enabling E2E labelling oversight, i.e. from confirmation of safety signal to label implementation ‘in pack’.

Presented by Denis Fung, Senior Managing Consultant at Navitas, this webinar will look to address the following:
  • End-to-end labelling – why is it important?
  • Patient Safety
  • PV Compliance
  • A new paradigm of E2E labelling – from signal to patient
  • What does good look like? Process, Governance, and Technology
  • One goal, one voice: the cross-functional paradigm (PV, RA, Supply Chain, Medical Affairs, etc.)
  • Looking forward
The webinar is aimed at professionals within Regulatory Affairs, Drug Safety and Pharmacovigilance, Clinical Development, QA, Artwork, Supply Chain, and others who would like to discover how to improve compliance and develop best practices in relation to E2E labelling.

If you would like further information, or you would like to register to attend this webinar, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

08
June 2015

Sparta Connection 2015

Date: 08-11 June 2015
Venue: Swan and Dolphin Resort in Orlando, FL, USA
Sparta Connection 2015



Navitas is the Gold Sponsor of Sparta Connection. Navitas’ Dave Gwyn will talk about the critical issues Life Science companies face with their TrackWise implementation, upgrades, data migration, reporting, integrations, support and the advantages of cloud hosting.

Also presenting at the conference are representatives from Roche, Johnson & Johnson, GE Healthcare, Otsuka, Janssen, Stryker, BD, Eli Lilly, Perrigo, Genentech and more.

10
Jun 2015

pvnet Summit

Date: 10 June 2015
Venue: Sidley Austin LLP offices in London
pvtech



Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

09
Jun 2015

pvconnect Forum

Date: 09 June 2015
Venue: Sidley Austin LLP offices in London
pvconnect



Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

09
Jun 2015

pvtech Forum

Date: 09 June 2015
Venue: Sidley Austin LLP offices in London
pvtech



pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

04
Jun 2015

labelnet Forum

Date: 04 June 2015
Venue: Sidley Austin LLP offices in New York
labelnet



Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

04
Jun 2015

pvtech Forum

Date: 04 June 2015
Venue: Sidley Austin LLP offices in New York
PVtech



pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

04
Jun 2015

pvconnect Forum

Date: 04 June 2015
Venue: Sidley Austin LLP offices in New York
pvconnect



Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

03
Jun 2015

rimnet Forum

Date: 03 June 2015
Venue: Sidley Austin LLP offices in New York
RIMnet



Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York City and London. The positive feedback from the participants, and the need for further discussion led to a second roundtable being held in fall 2015, again in both locations.
Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

02
Jun 2015

pvnet Summit

Date: 02 – 03 June 2015
Venue: Sidley Austin LLP offices in New York
pvnet



Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

21
May 2015

rimnet Forum

Date: 21 May 2015
Venue: Sidley Austin LLP offices in London
RIMnet



Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York City and London. The positive feedback from the participants, and the need for further discussion led to a second roundtable being held in fall 2014, again in both locations.

Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

19
May 2015

labelnet Forum

Date: 19 – 20 May 2015
Venue: Sidley Austin LLP offices in London
Labelnet



Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

17
May 2015

Pharma SUG Annual Conference

Date: 17-20 May 2015
Venue: Ornaldo, FL, US
Pharma SUG Annual Conference



Navitas will present “Accelerate define.xml generation using Define Ready” at the Pharma SUG Annual Conference in Orlando, May 18th at 9:30a.m. in the Oceans Ballroom 3 at the Renaissance Orlando at Seaworld. The presentation looks at the FDA & other regulatory agencies mandate of electronic submissions and standardized data, along with CDISC SDTM and ADaM based standards. An important component of such submissions is the generation of the CRT-Data Definition Document (Define xml).

12
May 2015

Benefit:Risk Management (BRM) webinar

Date: 12 May, 2015

Time: 16:30 – 18:00 Central European Time
15:30 – 17:00 British Summer Time
10:30 – 12:00 Eastern Daylight Time

Navitas are excited to announce the second webinar of our series, focusing on the topic of Benefit:Risk Management (BRM).

Health Authorities around the world require that Life Sciences companies perform comprehensive evaluations of their products’ Benefit:Risk relationships throughout their lifecycles, based on information sourced from numerous stakeholders who have not traditionally been intimately engaged in pharmacovigilance activities. In response, companies are establishing and refining processes, tools, and governance structures to ensure that all relevant efficacy and safety information is considered, and that related decisions are implemented and effective. Increasingly sophisticated methods to gather and analyse safety and benefit information are being employed, responding to the challenges associated with doing so, addressing the implications of the results, and monitoring the effectiveness of their responses to these analyses.

The environment continues to evolve, however, as both patients and payers follow and analyse Benefit:Risk information more closely and, in fact, base selection and reimbursement decisions on this information. As a result, companies must respond to current requirements regarding Benefit:Risk analysis while closely monitoring and responding to the expectations of regulators, payers, and patients as these requirements mature. The ability to meets these expectations will directly impact a product’s success in the market, so the stakes are high.

Presented by Sharmila Sabaratnam, Managing Consultant at Navitas, this webinar will look to address the following:
  • The BRM bar has been raised – a look at the drivers and the context
  • Industry status today
  • A model for success
  • BRM framework
  • Collaboration in action
  • Capability requirements
  • Tracking solutions
  • A look to the future
Aimed at Drug Safety, Clinical Research, Regulatory Affairs, GxP QA, and Market Access Professionals.

For further information, or if you would like to register to attend this webinar, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

11
May 2015

DIA’s eRegulatory and Intelligence Annual Conference

Date: 11-13 May 2015
Venue: Sheraton Philadelphia Downtown Hotel, Philadelphia, PA 19103
DIA eRegulatory and Intelligence Annual Conference



Navitas will be at booth 110 at the DIA eRegulatory and Intelligence Annual Conference, May 11th – 13th in Philadelphia, PA. Regulatory Information Management (RIM) is a key topic in the Life Science Industry and Navitas will highlight how content management is the key component to RIM. RIM looks at regulatory issues as an end-to-end process, and content management is the cornerstone of all regulatory activities.

4
May 2015

CDISC Europe Interchange

Date: 4–8 May, 2015
Venue: Congress Center Basel, Basel, Switzerland
CDISC Europe Interchange



Navitas is pleased to sponsor the CDISC Europe Interchange in Basel, Switzerland May 4th – 8th. Georgina Wood, Navitas’ Clinical Data Services practice lead, will speak about exciting new opportunities in the clinical data space concerning data warehousing with Oracle’s LSH/DMW as well as data visualization and statistical computing. Ms. Wood was formerly Global Head of Technology Innovations at Novartis.

4
May 2015

EMC World

Date: 4–7 May, 2015
Venue: The Venetian. Las Vegas, NV, USA
EMC World



Navitas will be presenting Regulatory Information Management (RIM) for the Life Sciences industry at EMC World Las Vegas, May 4th – 7. Life Science companies are IP driven and Navitas will demonstrate how technology, the Next Generation User Interface and process are the keys to Regulatory excellence.

16
Apr 2015

Live Webinar - SMB Compliance Solution for May 2015 Deadline - US Federal Drug Supply Chain Security Act

Date: 16 April, 2015
Time: 3 PM IST



Join Axway’s leading expert, Peter Stokes and Navitas’ Associate Vice President, B Sivanandam on this timely webinar as you prepare to comply with DSCSA requirements for lot level traceability by May 1st, 2015.

View On-Demand Webinar

14
Apr 2015

Women’s Life Sciences Network

Date: 14 April, 2015
Time: 18:00 – 20:45
Venue: Hyatt Regency Paris Etoile, Paris, France
oracle industry connect



Navitas Principal Consultant, Louise Jebson, will be attending the Sidley event ‘Women’s Life Sciences Network’. The event will feature a panel discussion with:

Lidia Retkowska-Mika, Co-chair, DIA EuroMeeting 2015 and Director of Legal Department, Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)
Paula Salmikangas, Chair of Committee for Advanced Therapies (CAT), European Medicines Agency (EMA) & Senior Researcher, Finnish Medicines Agency (FIMEA)
Isabelle Clamou, Director, Global Regulatory and R&D policy – Europe, Amgen

If you would like more information or have any questions please contact Cristina Menendez Ruiz at This email address is being protected from spambots. You need JavaScript enabled to view it.

13
Apr 2015

27th Annual DIA Euromeeting 2015

Date: 13-15 April, 2015
Venue: Palais des Congrès, Paris, France
oracle industry connect



Navitas Principal Consultant, Louise Jebson, will be attending the 27th Annual DIA Euromeeting as a delegate. The event this year is titled ‘Advancing Innovation to Combat the Global Burden of Disease: A Call to Action’. The meeting will address 12 themes across 5 core competencies: Clinical Development, Pharmacovigilance, Regulatory, Health Economics, and Quality and Safety

If you would like to arrange to meet with Louise, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

13
Apr 2015

IDMP webinar

Date: 13 April, 2015

Time: 16:30 – 18:00 Central European Time
10:30 – 12:00 Eastern Daylight Time
15:30 – 17:00 British Summer Time
07:30 – 09:00 Pacific Daylight Time
20:00 – 21:30 India Standard Time
Navitas are excited to announce the first webinar in our series, focusing on the topic of IDMP.

As most, if not all, pharmaceutical companies are aware, from July 2016 internally agreed terminology for the classification, retrieval, presentation, risk benefit evaluation, and assessment of pharmacovigilance and medicinal product information will become legally enforceable. These requirements apply to member states, Marketing Authorisation Holders (MAHs), and the Agency (EMA). The vehicle of choice is a set of five ISO standards, generally referred to as the Identification of Medicinal Products, or IDMP.

There is no doubt, from an objective perspective, that what IDMP proposes makes good sense. However, it does raise challenges for implementation, especially so within an industry that is under commercial pressure to cut annual budgets and reduce headcount. There are many different ways to ensure compliance with regulatory requirements, but there are only a few ways that ensure a long-term sustainable solution is in place; any solution to IDMP must be thought of holistically.

Presented by Rens van den Boomen, Senior Consultant at Navitas, this webinar will look to address the following:
  • Regulatory drivers for IDMP
  • What it means in reality
  • IDMP Readiness – how well do you know your products?
  • Roadmap to success – how to prepare and get return on your investments?
  • Where next?
Whether you are Head of Regulatory Affairs, a QPPV, managing a labelling department or are currently involved in XEVMPD submissions; IDMP will become an important aspect of your working life very soon. If you would like further information, or you would like to register to attend this webinar, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

31
Mar 2015

4th Annual Clinical Data Integration and Management

Date: 31 March – 1 April, 2015
Venue: Princeton, NJ
Annual Clinical Data Integration and Management



Clinical Data Analysts from Navitas will present “Using Data Standards to Improve Efficiency in the Set – Up of Clinical Trials” at 10a.m. on March 31st. The Significance & efficiencies of CDASH in terms of traceability & consistency of d&& collaboration functionalities, and more will be covered

26
Mar 2015

Oracle Industry Connect 2015

Date: 26 March, 2015
Venue: Washington Hilton, Washington DC, USA
oracle industry connect



Navitas CEO, Jim Tizzard, will be attending this Oracle event as well as being part of a panel examining how digitising data is transforming clinical trials and exploring its impact on the future of clinical development. The session, titled ‘Digital Trials and Research Models of the Future’ will be chaired by Mukhtar Ahmed, Global Vice President Life Sciences Strategy, at Oracle.

Oracle Industry Connect is a two day conference where industry peers share deep domain expertise, insights, and best practices about the mission critical applications core to their business. This event is exclusive and invitation only.

If you would like to arrange to meet with Jim, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

16
Mar 2015

India - TrackWise User Group (TUG)

Date: 16 March, 2015
Venue: Hyatt Regency, Mumbai

Navitas and Sparta Systems will host the first TrackWise User Group (TUG) event on 16th March 2015 at the Hyatt Regency, Mumbai. This event will serve as a platform for TrackWise users from this region to connect and share their experiences and TrackWise EQMS best practices with each other. Users can also learn from experts on how to get more from their investments in TrackWise.

14
Mar 2015

PhUSE - Pharmaceutical Users Software Exchange - Mumbai

Date: 14 March, 2015
Venue: TTC Industrial Area, MIDC Navi Mumbai, India
SAP



Navitas is participating, sponsoring and presenting a session on eSubmissions – an overview in PhUSE Single Day Event. PhUSE is an independent, not-for-profit organization run by volunteers. Since its inception, PhUSE has expanded from its roots as a conference for European Statistical Programmers, to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals.

11
Mar 2015

SAP TechEd Bangalore

Date: 11 - 13 March, 2015
Venue: Bangalore International Exhibition Centre
SAP



Navitas is one of the sponsor at this prestigious event. We will be showcasing our SAP certified mobility framework for Pre-Manufacturing, Plant Maintenance and Warehouse Edge System. SAP TechEd is the premier technical education conference for IT architects, administrators, and developers – offering more than 500 hours of training on SAP technology for in-memory computing, enterprise mobility, analytics, database, and the cloud.

26
Feb 2015

The Economist Pharma Summit

Date: 26 February, 2015
Venue: Radisson Blu Portman Hotel, London, UK

Navitas Director, Mike Giffin, will be attending The Economist Pharma Summit as a delegate.

The event, now in its 21st year, will focus on the challenges impacting the world of pharma, as well as the innovation required to face them. The Pharma Summit will address areas such as improving access and affordability of medicines, the immense differences between developed and emerging markets, technology in pharma, and enhancing partnerships across the ecosystem to benefit all.

If you would like to arrange to meet with Mike, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

24
Feb 2015

Virtue Insight 8th Pharmacovigilance 2015

Date: 24 – 25 February 2015
Venue: Marriott Marble Arch Hotel, London, UK
virtue insight Pharmacovigilance



Navitas Managing Consultant, Sharmila Sabaratnam, will be attending Virtue Insight’s 8th Pharmacovigilance conference as a delegate.

The conference will bring together top pharmaceutical, biotechnology, and regulatory representatives to address key industry issues. The program will cover the detection, analysis, and prevention of adverse drug reactions with the aid of case studies and industry experiences.

If you would like to arrange to meet with Sharmila, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

28
Jan 2015

NJ CDISC Users Group Meeting

Date: 28 January, 2015
Venue: Navitas Inc., Princeton, NJ, United States
virtue insight Pharmacovigilance




Navitas hosted this event at our US site. The attendes appreciated the quality of content presented during the event. The event focused towards Metadata management and ADaM analysis based discussions. The meeting was also organized via web-conferencing for remote access.

On-Demand Webinar

Navitas Networks On-Demand Webinar & Slides: E2E labeling – Achieving Global Consistency



Hosted by Navitas Networks this webinar is presented by Tara Baer.
The webinar addresses the following:

  • The Global labeling Context
  • Building Global connections
  • Looking forward


View On-Demand Webinar

On-Demand Webinar

Navitas and Sparta Systems - On-Demand webinar - Ensuring Data Integrity, Mitigating Risk and Quality Metrics



This webinar addresses the key challenges life sciences’ manufacturers face and the importance of:

  • Managing quality processes, data and 'metrics' consistently and accurately
  • A Quality Management System (QMS) with inherent analytical capabilities:
  • Reduces audit time and findings
  • Decreases risk of product recalls
  • Enables better decisions faster without the high costs of implementing and maintaining an external business intelligence solution


View On-Demand Webinar

On-Demand Webinar

Navitas Networks On-Demand Webcast & Slides: IDMP – Getting Ready



Hosted by Navitas Networks this webinar is presented by Navitas’ Senior Consultant Gary Aldam.

The webinar addresses the following:

  • The evolving IDMP regulatory landscape
  • How does industry prepare?
  • Getting Ready for IDMP
  • Looking forward


View On-Demand Webinar

On-Demand Webinar

Navitas Networks and AbbVie On-Demand Webcast & Slides – PV Organisations Reimagined – Roadmap to transforming into a strategic PV organisation



Hosted by Navitas Networks and AbbVie, this webinar is presented by Navitas’ Principal Consultant, Wilfred Gilich and, from AbbVie, Dr. Linda Scarazzini, Vice President PV and Patient Safety, Jenifer Koeller, Senior Director Business Solutions PV and Patient Safety, and Kemi Yusuf, Director Business Solutions Project Management PV and Patient Safety.


View On-Demand Webinar

On-Demand Webinar

Navitas’ pvindia On-Demand Webcast: Getting Inspection Ready



Hosted by Navitas’ pvindia Network, and presented by Louise Jebson, Head of Networks at Navitas Life Sciences and Jean-Christophe Delumeau, Head of Pharmacovigilance China and Asia Pacific at Bayer HealthCare, this webcast will explore the topic of ’Getting Inspection Ready’.


View On-Demand Webinar

On-Demand Webinar

On-Demand Webcast & Slides: Next Generation PV Tools



Hosted by Navitas Networks, this webcast is presented by Navitas’ Senior Consultant, Martin Holm-Petersen. The webcast will address the following:

  • IT as the game changer
  • What does digitally transformed PV look like?
  • Building IT strategies for PV


View On-Demand Webinar

On-Demand Webinar

On-Demand Oracle Webinar Series: Application Management Services



Navitas’ Application Management Services (AMS) allow you to get the most out of your IT investments by reducing your cost of management and support, whilst increasing customer satisfaction and quality of service. This webinar will talk you through the Navitas application lifecycle approach.


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On-Demand Webinar

On-Demand Oracle Webinar Series: Increase your upgrades to reduce your cost and complexity



The right strategy for upgrading your Argus safety database will save you money, effort and ensure that you have a system that fully supports your business needs and objectives. In this webinar we will talk you through Navitas’ forward thinking approach to system upgrades.


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On-Demand Webinar

On-Demand Oracle Webinar Series: Data Migration



Migrating legacy safety applications can be a daunting task due to the complexities involved. Navitas has prebuilt migration packages that enable rapid, compliant migrations from legacy applications (as well as Excel spreadsheets) to help smooth your implementation and provide peace of mind.


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On-Demand Webinar

On-Demand Oracle Webinar Series: Accelerated Argus Implementations



Navitas has been working with the Safety departments of the world’s leading pharmaceutical companies through consulting and our pvnet & pvconnect for over 15 years. We have used our unique insight to develop industry leading accelerators that automatically configure the Argus Safety application to significantly reduce implementation times.

This webinar will explain how our accelerators can fast track your Argus implementation whilst ensuring it is tailored to your specific business requirements.


View On-Demand Webinar

On-Demand Webinar

On-Demand Oracle Webinar Series: Oracle Argus in the Cloud



More and more companies, both small and large, are moving to the cloud, but it’s important you choose the right hosted environment for your business. This webinar will talk you through the advantages of cloud implementations, our expedited approach to implementation and the options open to you.


View On-Demand Webinar

On-Demand Webinar

On-Demand Webcast & Slides: End-to-End Labeling Tracking Tools in Action



Hosted by Navitas Networks, this webcast was presented by David Gwyn, Head Technology Practice at Navitas Life Sciences, Inc. and Craig Trautman, CEO, Intagras.
The webcast will address the following:

  • A reminder of why E2E tracking is key
  • The start and end point of labeling
  • Tracking tools in action
  • Looking forward

View On-Demand Webcast

On-Demand Webinar

Webcast Slides: IDMP - IDentification of Medicinal Products From concept to reality



Hosted by Navitas Networks, this webcast was presented by Rens van den Boomen, Managing Consultant at Navitas Life Sciences and will address the following:

  • Latest Regulatory context for IDMP
  • IDMP – 5 steps to success
  • Maturity Assessment
  • Strategy Roadmap
  • Program Management
  • System Implementation
  • IDMP Deployment

View On-Demand Webcast

On-Demand Webinar

On-Demand Webinar: Content Management in Minutes: Legal Contract Management - Navitas and Generis



Control your contracts by leveraging the power of metadata. Register to view: A dashboard of upcoming contract renewals, determine the value of what is ahead combined with the workload and the resources needed. The capabilities of creating contracts easily from templates and populating specific contract variables (vendor name, ID and so on) into the Word document on creation.


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On-Demand Webinar

On-Demand Webinar: Content Management in Minutes: Human Resource Management - Navitas and Generis



Take your HR environment to the next generation while leveraging your current content management investment. Register and watch a brief 30-minute session on Content Management in Minutes: Human Resource Management.


View On-Demand Webinar

On-Demand Webinar

On-Demand Webinar: Content Management in Minutes: Quality - Navitas and Generis



Register and see how you can manage your standard operating procedures (SOP), work instructions, specifications, analytical methods and other quality-related documents in a simple yet powerful user interface.


View On-Demand Webinar

On-Demand Webinar

On-Demand Webinar: Content Management in Minutes: Correspondence Management - Navitas and Generis



Register and watch how you can track communications more effectively by collating all information together in a single entity in your repository. Witness the integration of emails with attachments from a regulatory authority being stored as combined PDF document, complete with a forms-based manifestation of all critical metadata about the correspondence. Reduce your stress level when tracking and responding to health authorities with the next-generation user experience.


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On-Demand Webinar

On-Demand Webinar: Content Management in Minutes: Mobile Access - Navitas and Generis



Register to view demonstration showing interaction between a user on a desktop client and a user on their mobile phone. See how efficient it can be to work remotely using a custom-built application instead of a mobile browser, logging in with a scan of a thumbprint and signing a document without putting a pen to paper.


View On-Demand Webinar

On-Demand Webinar

On-Demand Webinar - Content Management in Minutes: Electronic Trial Master File (eTMF) - Navitas and Generis



Register to learn how to manage your TMF electronically, reducing your dependence on paper files while maintaining a compliant repository. See how you can scale this platform by selectively opening access to external partners and providing a user experience that Principal Investigators and Clinical Research Assistants can use without training. Experience an integrated solution that connects with your regulatory submission platform to enable sharing of documents and eliminating duplicates and mistakes.


View On-Demand Webinar

On-Demand Webinar

Webinar Slides: End-to-End Labeling – New Frontiers



Label management is a complex activity that is on-going throughout the lifecycle of a pharmaceutical product. Effective labeling, from label creation and updates through to implementation, is a truly cross-functional process which spans across Pharmacovigilance, Regulatory Affairs, Medical Affairs, and Supply Chain. The need to have E2E labeling oversight is now a regulatory expectation and no longer just a future requirements.
Register to download webinar presentation slides held on July 01, 2015.

View On-Demand Webinar

On-Demand Webinar

SMB Compliance Solution for May 2015 Deadline - US Federal Drug Supply Chain Security Act



Register and view this on-demand Webinar where we will discuss the requirements and challenges for compliance with the US Federal Drug Supply Chain Security and Axway’s solution, especially tailored to the requirements of Small and Medium Businesses.

View On-Demand Webinar

On-Demand Webinar

How to reduce the cost and complexity of complying with chain of custody and track and trace regulations including DQSA



Greater Compliance and Risk reduction are key considerations for Pharma companies worldwide. Advancements in technology and mobility solutions have created new avenues for pharmaceutical companies to improve business performance. However, leveraging mobility to reduce risk & increase compliance is an area that is still in its infancy!

View On-Demand Webinar

On-Demand Webinar

Process excellence & compliance through enterprise mobility solutions



Register to listen Axway’s leading expert, Atif Chaughtai and Navitas’s head of implementation, B Sivanandam as you prepare to comply with DSCSA requirements for lot level traceability...

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On-Demand Webinar

CARA for Documentum & Alfresco in the Cloud



Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum & Alfresco users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the final chapter in a six-part series showcasing CARA as the next generation user interface, and now in the cloud!

View On-Demand Webinar

On-Demand Webinar

CARA for Regulatory Information Management



Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the fifth in a six-part series showcasing CARA as the next generation user interface.

View On-Demand Webinar

On-Demand Webinar

CARA for eTMF



Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum and Alfresco users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the fourth in a six-part series showcasing CARA as the next generation user interface.

View On-Demand Webinar

On-Demand Webinar

CARA for Regulatory Affairs and Submission Management



Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum and Alfresco users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the third in a six-part series showcasing CARA as the next generation user interface.

View On-Demand Webinar

On-Demand Webinar

CARA for Controlled Content / Quality Document Management



Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the second in a six-part series showcasing CARA as the next generation user interface.

View On-Demand Webinar

On-Demand Webinar

The next generation user interface for Documentum and Alfresco



Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum and Alfresco users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the first in a six-part series showcasing CARA as the next generation user interface.

View On-Demand Webinar

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Dec2015

Steve Arlington, Navitas Advisor, Spoke on the Challenges, Opportunities and...

Steve Arlington, Navitas Advisor, Spoke on the Challenges, Opportunities and Future of the Pharmaceutical...

03
Nov2015

The changing trends in drivers of life sciences R D...

Outsourcing is not new in the life sciences sector. Clinical research outsourcing, contract sales...