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Session 3: Regulators – Inspection Feedback
Session Chair(s)
Sophie Radicke, MSc
Head of GPvP and Senior Pharmacovigilance Inspector
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Elspeth McIntosh, MBA, RN
Director
Castle Pharmacovigilance Ltd, United Kingdom
Patient access to safe and effective medicines is a key objective for both regulators and pharmaceutical companies. Information sharing between regulators and industry, including best practice examples and instances where things have gone wrong, contributes to better quality standards for pharmacovigilance, increased compliance across the board, and ultimately the goal of assuring patient safety. This session will give attendees an insight into the collaboration between inspectors from different regulatory authorities. In addition, we will discuss industry and inspectorate perspectives on how to improve information sharing and collaboration to increase pharmacovigilance system compliance and inspection readiness.
Speaker(s)
EMA PV Inspectors Working Group
Dunja Vukic, MPharm
European Medicines Agency, Netherlands
Scientific Administrator
MHRA Co-Operation with Other Global Agencies
Sophie Radicke, MSc
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Head of GPvP and Senior Pharmacovigilance Inspector
National Authority Perspective
Pieter Grotenhuis
Health and Youth Care Inspectorate, Netherlands
Senior Inspector for Pharmacovigilance
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