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Session 4: Inspections - Expectations And Interactions
Session Chair(s)
Claire Longman, MSc
Expert Pharmacovigilance Inspector
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
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)
Inspection Findings and Inspectorate Cooperation Trends
Claire Longman, MSc
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Pharmacovigilance Inspector
International Collaboration: PV collaboration between Ghana, MHRA & MEB
Adela Ashie
Food and Drugs Authority, Ghana
Principal Regulatory Officer
Industry Experiences with Inspections - More countries with less experience
Pat Harding
Eli Lilly and Company, United Kingdom
Senior Advisor, Medicines Quality Organisation – International,
Managing the Perfect Deviation – Regulatory and Industry Perspective
Claire Longman, MSc
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Pharmacovigilance Inspector
Managing the Perfect Deviation – Regulatory and Industry Perspective
Lauren Kelly
Bristol-Myers Squibb, Ireland
Associate Director, PV Inspection Readiness & Deviation Management