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Session 5: Inspections Session - Will the Future of Inspections be more Connected?
Session Chair(s)
Claire Longman, MSC
Expert Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Maarten Lagendijk, MSC
Deputy EU QPPV, MSD, Netherlands
This session will explore the evolving landscape of pharmacovigilance inspections. Insights and key metrics will be shared, highlighting common observations, followed by a panel discussion of experts — including representatives from the European Medicines Agency, EU member state inspectors, and industry professionals— who will discuss the future of inspections and the opportunities for collaborations between health authorities. Topics will include inspection processes and standardisation, sharing information globally, and how emerging authorities can leverage established practices.
Speaker(s)
EMA Inspection Updates: Trends and Common Findings
Head of Inspections, European Medicines Agency, Netherlands
Inspector from a Member State: Metrics and Findings
GCP/PV Inspection Manager, Health Products Regulatory Authority (HPRA), Ireland
Panel Discussion: Future of Inspections and Opportunities for Collaborations between Health Authorities
Head, Global PV Compliance and Policy, Pharmacovigilance & Patient Safety, Abbvie, Portugal
Norleen Mohamed Ali
Head of Pharmacovigilance Section, Center for Compliance & Quality Control, National Pharmaceutical Regulatory Agency (NPRA), Malaysia
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