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Session 2: Globalisation Of PSMF : Practical Implementation
Session Chair(s)
Francoise Sillan, MD
EU1 UK QPPV, Ipsen, France
Willemijn van der Spuij, MSc
Executive Director Europe | International - Patient Safety, 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.
Speaker(s)
Sean Burke, MSc
(EFPIA IPVG Representative) Pharmacovigilance Lead, EEMEA, Merck , United Kingdom
Global Perspective on The Implementation of the PSMF
Aalaa Afdal Mogheith, MPA, MPharm
Head of Pharmaceutical Vigilance, General Administrator, Egyptian Drug Authority (EDA), Egypt
National Authority (outside EU)
Melanie Weber Weber, MSc
Pharmacovigilance Expert, Pietrek Associates Gmbh, Germany
Audit Perspective on the PSMF
Claire Longman, MSc
Expert Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
MHRA Perspective
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