July 29, 2016 Princeton, New Jersey:The Navitas Networks are pleased to confirm the dates for our upcoming Autumn forums. At Navitas we have over 15 years’ experience in hosting and facilitating roundtable discussion and forums with Life Sciences leaders, and are well known for our industry leading networks covering CMO, Pharmacovigilance, Labelling, and Regulatory Information Management. Further information and our calendar of events can be found below:
27 September, 2016 in Frankfurt: RA Roundtable – ‘How to ensure Regulatory Affairs is of relevance in 2025’
We are delighted to be hosting our first Regulatory Affairs Roundtable ‘How to ensure Regulatory Affairs is of relevance in 2025’. The roundtable will look to explore how Regulatory Affairs can provide strategic value within their organisations and within the pharmaceutical sector, whilst remaining affordable. Key themes for discussion include:
- Sharing perspectives on the changing landscape for RA and key drivers for change
- How to shift the RA perception from cost centre to ‘value added’
- Exploring the RA organisation of the future
25 October, 2016 at the Hyatt Regency Hotel, Mumbai: pvindia Forum
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
03 November, 2016 at Amgen Headquarters, Thousand Oaks, CA, USA: labelnet Satellite Meeting
As a response to rapidly increasing labelnet membership, this year we will host a satellite meeting aimed at Biologics companies. The agenda aims to address the specific challenges associated with labelling for Biologics, Combination Products involving Biologics, and Biosimilars.
08 November, 2016 in London and 17 November, 2016 in New York: pvconnect Forum
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 will include building best practice for managing PV expansion and integration as well as approaches and best practices for PV outsourcing.
08 November, 2016 in London and 17 November, 2016 in New York: rimnet Forum
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.
09 November, 2016 in London and 16 November, 2016 in New York: labelnet Forum
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 November agenda will focus on adding value through optimum labelling; including labelling operations, documentation, and development labelling. Furthermore, we will look at how to best manage growth and change due to expending scope, M&A, collaboration, and new products.
09 November, 2016 in London and 16 November, 2016 in New York: pvtech Forum
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.
10 November, 2016 in London and 15 November, 2016 in New York: pvnet Strategic Summit
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 November agenda will focus on the expanding PV universe, digital transformation of PV, and the evolution of PV tools and automation.
We hope to see you at an event in the Autumn.
The Navitas team has been assembled bringing together the proven expert teams of TAKE Life Sciences and WCI Consulting and, adding to this core, a range of experts from the worlds of Clinical Development, Regulatory, Technology, and Consulting. We have built the Navitas team specifically to deliver insight to our clients, to develop pragmatic solutions together, and to support their deployment and operation. We deliver advise, solutions, and services in Clinical, Regulatory, Safety, and Content Management. We are proud that our legacy businesses have served the sector for some 20 years and have allowed us to work with 100 of the top Life Science companies. Our team have now grown to over 400 staff.
We pride ourselves in our role as Expert Navigators. Interpreting market and regulatory change; driving collaboration across companies; seeking the simple solution to the complex problem; investing to enable the changes. Motivated by the success of our clients, we thrive on working together with clients, partners, and each other, across geographies, time zones, and cultures. For more information, visit www.navitas.net.