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Mercure Amsterdam City Hotel

08 nov 2023 8:30 a.m. - 09 nov 2023 5:15 p.m.

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

This Forum provides valuable insights into the most pressing issues QPPVs are facing today. This event has limited capacity, register early!

Session 4: Inspections - Expectations And Interactions

Session Chair(s)

Claire  Longman, MSc

Claire Longman, MSc

Expert Pharmacovigilance Inspector

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

Willemijn  van der Spuij, MSc

Willemijn van der Spuij, MSc

Executive Director, WorldWide Patient Safety International, Europe

Switzerland

This session will address both a regulatory perspective and an industry perspective on inspections. The audience will learn about inspection findings and trends and in addition, also hear what it means to manage inspections in multiple countries and how to handle different expectations. The future of inspections will also be addressed to give the audience a broad insight into various aspects of inspections.

Speaker(s)

Claire  Longman, MSc

Inspection Findings and Inspectorate Cooperation Trends

Claire Longman, MSc

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

Expert Pharmacovigilance Inspector

Adela  Ashie

International Collaboration: PV collaboration between Ghana, MHRA & MEB

Adela Ashie

Food and Drugs Authority, Ghana

Principal Regulatory Officer

Pat  Harding

Industry Experiences with Inspections - More countries with less experience

Pat Harding

Eli Lilly and Company, United Kingdom

Senior Advisor, Medicines Quality Organisation – International,

Claire  Longman, MSc

Managing the Perfect Deviation – Regulatory and Industry Perspective

Claire Longman, MSc

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

Expert Pharmacovigilance Inspector

Lauren  Kelly

Managing the Perfect Deviation – Regulatory and Industry Perspective

Lauren Kelly

Bristol-Myers Squibb, Ireland

Associate Director, PV Inspection Readiness & Deviation Management

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