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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
EUQPPV, Takeda Pharmaceuticals, Sweden
EMA Pregnancy Guidelines
EMA liaison official to the US FDA, European Medicines Agency, Netherlands
IMI Conception Project
Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance, Novartis Pharma Gmbh, Switzerland
Panel discussion with Q&A, with the additional participation of:
Quality and Safety Policy Executive (MRPharmS), The Association of the British Pharmaceutical Industry (ABPI), United Kingdom
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