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Sep 07, 2021 7:00 PM - Sep 10, 2021 12:30 AM

(Central Europe Standard Time)

Pharmacovigilance Strategies Workshop

Navigating the changing PV landscape in your daily work. Anniversary edition: 5 years

Session 1: Pharmacovigilance Guidelines And Regulations Updates (EU, Non-EU, Global)

Session Chair(s)

Maarten  Lagendijk, MSc

Maarten Lagendijk, MSc

Deputy EU QPPV

MSD, Netherlands

Willemijn  van der Spuij, MSc

Willemijn van der Spuij, MSc

Executive Director, WorldWide Patient Safety International, Europe


This session looks to explore multiple aspects of regulatory changes that impact Patient Safety and Pharmacovigilance activities from different regions around the world. Multiple PV topics will be addressed; starting with an FDA perspective on combination product regulations followed by an update on the EMA GVP for RMM; the next topic will cover ICH E2D activities and specifically an update on the discussions that are taking place; the latest on EV monitoring for signals and the industry experience; an update on the Clinical Trial Regulation that is nearing its implementation; and finally, an update on the ICH E2B activities in an international context. A lot of work is taking place in the emerging markets to promote ICHE2B standards, so the final topic in this session will be truly international.


Nuria  Semis-Costa, MSc

EMA GVP on RMM: Updates from a Regulator : Nuria Semis-Costa, MSc

Scientific Specialist (Risk Management)

European Medicines Agency, Netherlands

Vicki  Edwards, RPh

Updates on ICH E2D: Post-Approval Safety Data Management: Vicki Edwards, RPh

Vice President, Pharmacovigilance Excellence and International QPPV

Abbvie, United Kingdom

Martin  Huber, MPH, MPharm

EV/EVDAS: Updates : Martin Huber, MPH, MPharm

Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair

Federal Institute for Drugs and Medical Devices (BfArM), Germany

Elke  Stahl, PhD

CTR and Implementing Act : Elke Stahl, PhD

Senior Expert, Clinical Trials Department

Federal Institute For Drugs and Medical Devices (BfArM), Germany

Jean-Christophe  Delumeau, MD, PhD

Updates on ICH E2B : Jean-Christophe Delumeau, MD, PhD

Senior Expert

Institute of Pharmacovigilance, Czech Republic

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