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Session 4: Trends in Inspections
Session Chair(s)
Sophie Radicke, MSc
Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Session Overview: This session will provide an in-depth look at current and emerging trends in UK pharmacovigilance inspections. MHRA representatives will outline recent operational updates, key findings, and evolving expectations - including insights from NIS-related inspections, the Implementing Regulation, and much more. Attendees will gain a clearer understanding of inspection priorities, common challenges, and how to prepare effectively for the changing inspection landscape.
Speaker(s)
Helen Emery
Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Inspection Trends, Metrics and Hot Topics
Anastasia Daskajiannis St John
GPvP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Regulatory Updates
Silvia Danesi
Pharmacovigilance Inspector, Healthcare, Quality and Access group, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Joint Inspections with Health Canada
Pramod Wable
Director, Inspection Management Team Lead, Pfizer, United Kingdom
Joint Inspections with Health Canada
Valentina Chavez Lara
Pharmacovigilance Country Head UK and IE / UK QPPV, Bayer Plc, United Kingdom
Joint Inspections with Health Canada
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