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Pharmacovigilance Strategies Workshop

Engage in the sharing of good practices between industry representatives and seek advice from regulators in this unique workshop

Session 2: Globalisation Of PSMF : Practical Implementation

Session Chair(s)

Francoise  Sillan, MD

Francoise Sillan, MD

  • Ipsen, France
Willemijn  van der Spuij, MSc

Willemijn van der Spuij, MSc

  • Executive Director, WorldWide Patient Safety International, Europe
  • Bristol Myers Squibb, Switzerland

This session focusses on the PSMF requirements from a global perspective. With the expansion of PSMF, or similar, requirements, better understanding the landscape in which we operate will be beneficial to participants. Through the lens of various experts we will be looking at how varying global requirements impact the concept of the PV system and its description, its development and maintenance. The session will cover a deep dive into some of the PSMF requirements outside the EEA. We will explore the learnings to be taken from audit findings by looking at what trends have been observed and can be used as part of the global consideration and improvements. And the session will include a regulators view, what are the requirements and expectations specific to the UK for the PSMF. Why are these requirements so important.

The Q&A as part of this session will allow the participants to interact with the experts and discuss considerations for pragmatic ways of working for the PSMF in the global environment.


Sean  Burke, MSc

Global Perspective on The Implementation of the PSMF

Sean Burke, MSc

  • Pharmacovigilance Lead, EEMEA
  • Merck , United Kingdom
Aalaa  Afdal Mogheith, MPA, MPharm

National Authority (outside EU)

Aalaa Afdal Mogheith, MPA, MPharm

  • Head of Pharmaceutical Vigilance, General Administrator
  • Egyptian Drug Authority (EDA), Egypt
Melanie Weber Weber, MSc

Audit Perspective on the PSMF

Melanie Weber Weber, MSc

  • Pharmacovigilance Expert
  • Pietrek Associates Gmbh, Germany
Claire  Longman, MSc

MHRA Perspective

Claire Longman, MSc

  • Interim Head of GCP and Senior Pharmacovigilance Inspector
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

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