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Renaissance London Heathrow Hotel

Oct 10, 2018 8:00 AM - Oct 11, 2018 4:30 PM

Bath Road, Hounslow, Middlesex, TW6 2AQ, United Kingdom

2018 European Forum for Qualified Person for Pharmacovigilance (QPPV)

Session 2: Hot Topics – Industry Perspectives, What Do I Need to Know?

Session Chair(s)

Vicki  Edwards, RPh

Vicki Edwards, RPh

Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom

This will be year four for this very popular session. Typically the session invites speakers who are leading discussions between industry trade associations and Regulatory Authorities on the key issues of the moment. The session provides insight into what are the hot topics under discussion, what progress has been made and what are the next steps. The session is of value to participants from both large and small companies alike as there is limited attendance possible at the public meetings with EMA so this is a fantastic opportunity to hear about these topics from individuals who are directly involved. The session consists of a series of short, concise presentations that cover the key messages. This session is always a crowd pleaser!

Speaker(s)

Sue  Rees, MS

Sue Rees, MS

Director , Sue Rees Consultancy Ltd, United Kingdom

Update on collection of safety data from PSPs

Margaret Anne Walters

Margaret Anne Walters

Deputy EU Qualified Person for Pharmacovigilance, Merck, Sharp & Dohme Ltd, United Kingdom

Update on EV new functionalities

Willemijn  van der Spuij, MSc

Willemijn van der Spuij, MSc

Executive Director Europe | International - Patient Safety, Bristol Myers Squibb, Switzerland

Update on RSI

Willemijn  van der Spuij, MSc

Willemijn van der Spuij, MSc

Executive Director Europe | International - Patient Safety, Bristol Myers Squibb, Switzerland

Country level signal notification requirements

Valerie E. Simmons, MD, FFPM

Valerie E. Simmons, MD, FFPM

Senior Medical Fellow, Global Patient Safety, Eli Lilly and Company Ltd, United Kingdom

EV Signalling Metrics

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