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Session 1: Recent and Future Development on Pharmacovigilance Practices
Session Chair(s)
Francoise Sillan, MD
EU1 UK QPPV
Ipsen, France
This session will be dedicated to future trends of regulations and guidelines within and outside Europe. Following Brexit, the move of EMA from London to Amsterdam and the recent COVID 19 pandemic this activity has been deprioritized since end 2018. This session will present the challenges on pregnancy and lactation safety monitoring from EMA, MHRA and IMI perspectives. There will be an update on the future developments of post approval safety data management with the revision of ICHE2D guideline by Expert Working Group which will include the revision of the management of reports from patient support programmes and market research programmes.
Speaker(s)
E2D: update of Post Approval Safety Data Management - Definition and Standards for Expedited Reporting
Johan Hellmér, MD, PhD
Takeda Pharmaceuticals, Sweden
EUQPPV
EMA Pregnancy Guidelines
Corinne de Vries, PhD, MA, MSc
European Medicines Agency, Netherlands
Head of Translational Sciences Office
IMI Conception Project
David John Lewis, PhD
Novartis Pharma Gmbh, Switzerland
Head QPPV PRRC Office, Patient Safety & Pharmacovigilance
Panel discussion with Q&A, with the additional participation of:
Belen Granell Villen
The Association of the British Pharmaceutical Industry (ABPI), United Kingdom
Quality and Safety Policy Executive (MRPharmS)
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