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Five Years On – Pharmacovigilance Legislation Delivers on Long-Promised Elements

What is the Future of Pharmacovigilance?

Day & Time:
April 19, 8:30AM - 10:00AM (Central Europe Standard Time)

Session Number:

Room Number:


Five Years On – Pharmacovigilance Legislation Delivers on Long-Promised Elements

Shelley Gandhi, MS
Strategic Advisor
NDA Group, United Kingdom

The main aims of the Pharmacovigilance (PV) Legislation in 2012 were to strengthen the protection of public health and rationalise PV by simplification of rules and procedures for all stakeholders, decreasing duplication, better definition of roles and responsibilities while simultaneously increasing transparency and further engaging healthcare professionals and patients. This session will focus on the experiences and assess the role of EudraVigilance (EV) as the single database in the EEA for ICSRs, how EV signalling is being piloted and examine the new PRAC process for public hearings to determine whether we are delivering on our aims which had been laid out 5 years ago.

Presentation(s) & Speaker(s):
Panel Discussion
Margaret Anne Walters
Deputy EU Qualified Person for Pharmacovigilance
Merck, Sharp & Dohme Ltd, United Kingdom

Panel Discussion
Steve Hobbiger
Senior Vice President and QPPV, R&D
GlaxoSmithKline , United Kingdom

Panel Discussion
Yusuf Tanrikulu
Principal PV Process Leader
F-Hoffmann-La Roche AG, Switzerland