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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
  • Bristol-Myers Squibb, Switzerland
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 Officer
  • European Medicines Agency, Netherlands
Vicki  Edwards

Updates on ICH E2D: Post-Approval Safety Data Management

Vicki Edwards

  • Vice President, Pharmacovigilance Excellence and International QPPV
  • AbbVie, Inc., United Kingdom
Martin  Huber

EV/EVDAS: Updates

Martin Huber

  • Pharmacovigilance Division, PRAC Member
  • Federal Institute for Drugs and Medical Devices (BfArM), Germany
Elke  Stahl, PhD

CTR and Implementing Act

Elke Stahl, PhD

  • CTFG Co-Chair, Clinical Trials expert
  • Federal Institute For Drugs and Medical Devices (BfArM), Germany
Jean-Christophe  Delumeau, MD, PhD

Updates on ICH E2B

Jean-Christophe Delumeau, MD, PhD

  • Head of pharmacovigilance Policy Strategy
  • Bayer Pharma, Singapore