DIA EUROPE 2019

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Forum on Global Pharmacovigilance

Session Chair(s)

Doris Irene Stenver, MD, MPA

Independent Pharmacovigilance Adviser

Unique Advice, Denmark

In this session a comparison of safety surveillance in the EU and USA, based on experiences with signal management, an outline of authorities’ expectations to PSURs and an update to the WHO´s Smart Safety Surveillance (3S) strategy will be provided.

Learning Objective : • Comparison of safety signals of 2017 identified by PRAC and FDA Adverse Event Reporting System (FAERS) to know about similarity and difference in approach of signal detection of two regulatory medicines agencies. • Comparison of the post-authorisation safety surveillance for medicinal products in the European Union and the United States of America

Speaker(s)

Comparison of the Management of Safety Signals between EU and USA for 2017

Arpit Vallabhbhai Vachhani, MD

Mylan Pharmaceuticals Private Limited, India

Deputy Manager

Periodic Safety Reports: What are the Authorities Expectations?

Menno Van Der Elst, PharmD, PhD

Medicines Evaluation Board, Netherlands

PRAC member

Update on the WHO Triple S Initiative

Shanthi Pal, DrSc, MPharm

WHO, Switzerland

Group Lead, Medicines Safety, Safety & Vigilance

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