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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)
Inspection Trends, Metrics and Hot Topics
Helen Emery
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Pharmacovigilance Inspector
Regulatory Updates
Sophie Radicke, MSC
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Head of GPvP and Senior Pharmacovigilance Inspector
Regulatory Updates
Anastasia Daskajiannis St John
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Pharmacovigilance inspector
Joint Inspections with Health Canada
Silvia Danesi
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Pharmacovigilance Inspector, Healthcare, Quality and Access group
Joint Inspections with Health Canada
Pramod Wable
Pfizer, United Kingdom
Inspection Management Team Lead
Joint Inspections with Health Canada
Valentina Chavez Lara
Bayer Plc, United Kingdom
Pharmacovigilance Country Head UK and IE / UK QPPV
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