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Congress Center Basel

Apr 17, 2018 2:00 PM - Apr 19, 2018 11:00 PM

Messeplatz 21 , CH-4021 Basel , SWITZERLAND

DIA EUROPE 2018

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

Session Chair(s)

Shelley  Gandhi, MSc

Shelley Gandhi, MSc

PV trainer

Independent, 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)

Margaret Anne Walters

Panel Discussion

Margaret Anne Walters

Merck, Sharp & Dohme Ltd, United Kingdom

Deputy EU Qualified Person for Pharmacovigilance

Steve  Hobbiger

Panel Discussion

Steve Hobbiger

GlaxoSmithKline , United Kingdom

Senior Vice President and QPPV, R&D

Yusuf  Tanrikulu

Panel Discussion

Yusuf Tanrikulu

Deutschland, Germany

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