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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
Peter Twomey, MA, MPharm
European Medicines Agency, Netherlands
Head of Inspections
Inspector from a Member State: Metrics and Findings
Christine Prendergast
Health Products Regulatory Authority (HPRA), Ireland
GCP/PV Inspection Manager
Panel Discussion: Future of Inspections and Opportunities for Collaborations between Health Authorities
Carrie Scott
Abbvie, Portugal
Head, Global PV Compliance and Policy, Pharmacovigilance & Patient Safety
Norleen Mohamed Ali
National Pharmaceutical Regulatory Agency (NPRA), Malaysia
Head of Pharmacovigilance Section, Center for Compliance & Quality Control