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Five Years On – Pharmacovigilance Legislation Delivers on Long-Promised Elements
Session Chair(s)
Shelley Gandhi, MSc
Strategic Advisor, Pharmacovigilance and Drug Safety
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.
Speaker(s)
Panel Discussion
Margaret Anne Walters
Merck, Sharp & Dohme Ltd, United Kingdom
Deputy EU Qualified Person for Pharmacovigilance
Panel Discussion
Steve Hobbiger
GlaxoSmithKline , United Kingdom
Senior Vice President and QPPV, R&D
Panel Discussion
Yusuf Tanrikulu
Deutschland, Germany
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