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Session 1: UK Regulatory Snapshot: What QPPVs Need to Know Now
Session Chair(s)
Lauren East
Head Pharmacovigilance and Medical Information / UK QPPV, 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)
Anne Carter
Consultant in Regulatory Affairs & Pharmacovigilance, Carter & Associates Ltd, United Kingdom
MHRA Portal and ICSR submissions
Nadine Anderson
Benefit Risk Assessor, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Safety Variation and Implementation in the UK
Emma Rooke
Benefit Risk Assessor, Medical Devices, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
The new Device Post Marketing Requirements
Helen Fiddes
Head of Patient Safety, UK and Ireland, Bristol-Myers Squibb, United Kingdom
UK CTR – Quick Update
Jason Wakelin-Smith
Expert GCP Inspector & Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
UK CTR – Quick Update
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