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Session 1: UK Regulatory Snapshot: What QPPVs Need to Know Now
Session Chair(s)
Lauren East
Head, Pharmacovigilance UK
Abbvie, United Kingdom
Louise Woodward, PHD
UK QPPV and Local Safety Responsible
Roche Products Ltd, United Kingdom
Session Overview: This session will provide a series of concise regulatory and operational updates on the most relevant UK developments impacting QPPVs. Speakers will cover recent changes to the MHRA Portal and ICSR submissions, the implementation of safety variations in the UK and their alignment with EU requirements, experience with the new device post-marketing requirements, and practical implications of the UK Clinical Trials Regulation. The session will also touch on the Medicines and Medical Devices Regulation consultation, offering participants clear, practice-focused takeaways to support compliant and efficient PV activities.
Speaker(s)
MHRA Portal and ICSR submissions
Anne Carter
Carter & Associates Ltd, United Kingdom
Consultant in Regulatory Affairs & Pharmacovigilance
Safety Variation and Implementation in the UK
Nadine Anderson
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
The new Device Post Marketing Requirements
Representative(s) / Speaker(s) Invited
Switzerland
UK CTR – Quick Update
Helen Fiddes
Bristol-Myers Squibb, United Kingdom
Head of Country Pharmacovigilance, UK and Ireland
UK CTR – Quick Update
Jason Wakelin-Smith
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Expert GCP Inspector & Head of Compliance Expert Circle
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