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Session 5: Inspections - What QPPV’s Need To Know
Session Chair(s)
Claire Longman, MSc
Expert Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Elspeth McIntosh, MBA, RN
Director, Castle Pharmacovigilance Ltd, United Kingdom
Session Overview: This session will explore the evolving landscape of pharmacovigilance inspections. Insights and key metrics will be shared, highlighting common observations and the role of QPPVs outside the EU. This will be followed by a panel discussion of experts — including representatives from EU member state and non-EU inspectors, with industry QPPV and QA colleagues. We will discuss current inspection trends and processes as well as practical aspects of managing and responding to multiple inspections by different authorities with differing expectations and priorities.
Speaker(s)
Latest Inspection Trends and Findings
Elena Rodionova
Pharmacovigilance inspector (Blood, Tissue and Vigilance), Austrian Agency for Health and Food Safety Ltd (AGES), Austria
Aise Sukran Renda, MBA
Senior Inspector, Chair of PIC/S AI/ML Working Group, Turkish Medicines and Medical Devices Agency (TMMDA), Turkey
Allison Jack
Executive Director | PV Quality Assurance, Bristol Myers Squibb (BMS), United Kingdom
Koen Van Der Heijden, MSc
Global QPPV, Deciphera Pharmaceuticals, Netherlands
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