Emerging agenda for our next meeting: Spring, 2017

  • Increasing business value from PV technology investments
  • Discuss alternative solutions and develop best practice aligned to the future of PV
  • New insights and methods of handling the ever increasing work load, requirements and complexities in the PV world.

Whilst drug safety can be a source of competitive advantage, there is a greater mutual benefit in sharing experience and common challenges.

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.

Latest insights and innovations in PV impacting the technology space

The PV Context and Driver

  • Relentless regulatory changes, with more on the horizon, e.g. ICH E2B R(3), IDMP, EU Clinical Trial Regulation, Eudravigilance, Medical Device Regulation
  • Shifting global boundaries, stagnating established markets, new models for emergent markets
  • Dramatic changes in the Pharma landscape will shape future PV models and processes>

The PV Challenges faced by member companies

  • Increased scrutiny by health authorities on regulatory changes and imminent deadlines for system implementation
  • Expanding remit of boundaries spanning outside of PV
  • Remaining compliant, driving efficiency and value with less resources
  • System availability from vendors meeting regulatory requirements (E2B R3 and IDMP) impacting technology buy/build decisions
  • Keeping systems validated and inspection ready
  • Gearing for future requirements

Recent PV Solutions debated by members

  • Latest regulatory insights: social media, data privacy, increasing enforcement, and the rise of quality
  • Working across boundaries - setting structured responsibilities and governance across the PV system
  • Comparative data analysis for driving lean operations, KPIs for now and the future
  • E2B R3 and IDMP readiness

PV Opportunities for further debate and predictions

  • Managing the data explosion from digital media: new, public, and unstructured sources
  • Leveraging technology to enable predictive analysis and safety…real-time Benefit-Risk?
  • Striking the balance of seamless integration: global consistency and local difference
  • Driving innovation with new capabilities to explore new PV systems and models for the futur

Why join pvtech?

  • Industry networking opportunities
  • Builds profile of company and PV function
  • Encourages sharing of ideas and strategic thinking
  • Provides quantitative and qualitative performance benchmarks
  • Access to the latest PV insights through webcasts, think tanks, community exchange
  • Brings to life good practices
  • Defines and prioritises improvement initiatives
  • Independent validation and facilitation

The network is exclusively for pvnet and pvconnect members. For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

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Latest News

20
Apr2017

ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and...

Navitas welcomes the opportunity to provide comments on this Reflection Paper... Navitas welcomes the opportunity...

13
Apr2017

Navitas Life Sciences Augments Global Executive Management Team

Navitas Life Sciences announced the appointment of Dr. Krishnan Rajagopalan as Chief Growth Officer....

24
Jan2017

Navitas Networks announce Forum dates for Spring, 2017

The Navitas Networks are pleased to confirm the dates for our upcoming Spring forums... ...

17
Jan2017

Navitas Launches Labeling Assessment Express

Regulators are changing the way they look at labeling. The emphasis is on ensuring...

02
Nov2016

BioVectra chooses pharmaREADY for eCTD Solution

BioVectra has chosen pharmaREADY for its eCTD requirements. BioVectra, located in Canada, manufactures...

05
Oct2016

Navitas at DIA's 10th Annual Forum for Qualified Persons...

Navitas Principal Jeffrey Ho will present "Efficient content management for the compilation and...

04
Oct2016

News 2016

[row id="1" class="ROW_CLASS"] [col class="span12"] 02 Nov 2016 AbbVie and Navitas Present Case Study on the Evolution...

27
Sep2016

Navitas releases paper on CDISC, the standards and why the...

The FDA (and eventually, regulatory agencies from around the world) will require clinical data...

13
Sep2016

AbbVie and Navitas Present Case Study on the Evolution and...

At 10:30a.m. (East Coast Time) on September 22nd, Navitas and AbbVie will...

29
Jul2016

Navitas Networks announce Forum dates for Autumn, 2016

The Navitas Networks are pleased to confirm the dates for our upcoming Autumn forums....

12
Jul2016

Navitas Celebrates 100th pharmaREADY customer

pharmaREADY is Navitas’ intuitive and easy to use, fully integrated, regulatory compliant, web-based suite...

28
Jun2016

Navitas' PVTech Summit Defines Future Success

Navitas’ PVTech Summit was held on June 15th at the Hudson Hotel in New...

18
May2016

Navitas Welcomes Tara Baer to Navitas

Navitas is pleased to welcome Tara Baer, who joins Navitas' Regulatory Practice. With over...

18
May2016

Navitas Speaks at Sparta Connection in Orlando

David Gwyn, Navitas' Technology Practice lead, will unveil idmpREADY at the Sparta Connection conference...

14
Mar2016

Navitas Earns Speaking Sessions at DIA’s 52nd Annual Meeting

In two different sessions, Subject Matter Experts from Navitas will address new challenges facing...

09
Mar2016

Navitas is pleased to announce the introduction of our networks...

Navitas' inaugural pvindia meeting took place in Mumbai on Thursday 03 March, 2016. ...

25
Jan2016

Navitas Announces the Inaugural pvindia Forum

Navitas will soon be adding to our portfolio of industry leading networks with the...

18
Jan2016

Navitas Relaunches pharmaREADY.com

pharmaREADY.com is Navitas' next generation website for its fully integrated, regulatory compliant document management,...

14
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...