Where will pharmacovigilance be in the next five years?


Sameer Thapar
01/31/2018

Ahead of the 2018 Pharmacovigilance summit, Sameer Thapar, Global Pharmacovigilance Operations & Compliance, Rutgers University discusses the future of pharmacovigilance.

What are the top 3 emerging trends or innovations impacting pharmacovigilance and why?

 Use of Artificial Intelligence in data management and analytics due to the need to get back operational efficiencies in the face of increasing case volumes; Increased adoption of automations and other rule-based configurations for processing intake and reporting of ICSRs due to the need for shifting through big data and volume overload; Pharmacovigilance governance reorganization due to the Brexit and future of the EU QPPV role for UK based persons.

If you had a blank check, what pharmacovigilance investment would you make and why?

I’d design a cloud enabled, role based, 3 tiered approach to intake, processing, and reporting that would be scalable, deployable as local or centralized unit, and resource agnostic (open to any who could be trained on it, not just medical/clinical professionals). The current structuring of PV departments fosters a data silo and redundancies.

When it comes to regulatory compliance, what are the top 2 challenges your organization currently faces?

Regulatory compliance has always been difficult since it is left to be subjective, more so in the US and developing countries not modeled on the EMA. Interpretation of regulations and hesitation of using common sense due to fear of inspection outcomes limits us.

What regulatory or legislative deadline or updates are you currently preparing for?

E2B R3 is the one of the major one we’re preparing for now.

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How do you view the patient perspective?

 Patients have become savvy in researching and outputting their stances onto social media. As an industry, we have been lax to count their views or give it significance. That is changing.

How do you see pharmacovigilance evolving over the next five years?

PV will evolve into consortiums of pharma companies, grouped by market depth and size, banding together to force clarity in regulations. There is power towards standardization when 10 companies interpret the guidance in the same manner.

Have you recently read any whitepapers that you found especially helpful?

Data Mining at the FDA whitepaper released in 2016 which provides an in-depth summary of the technologies the FDA is utilizing currently and planning on implementing that will automate its routine tasks