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KIT Royal Tropical Institute, Amsterdam

Nov 08, 2022 9:00 AM - Nov 09, 2022 5:15 PM

Mauritskade 63, 1092 Amsterdam, Netherlands

Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

Session 3: Regulators – Inspection Feedback

Session Chair(s)

Sophie  Radicke, MSc

Sophie Radicke, MSc

Head of GPvP and Senior Pharmacovigilance Inspector

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Elspeth  McIntosh, MBA, RN

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)

Dunja  Vukic, MPharm

EMA PV Inspectors Working Group

Dunja Vukic, MPharm

European Medicines Agency, Netherlands

Scientific Administrator

Sophie  Radicke, MSc

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

Pieter  Grotenhuis

National Authority Perspective

Pieter Grotenhuis

Health and Youth Care Inspectorate, Netherlands

Senior Inspector for Pharmacovigilance

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