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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 Europe | International - Patient Safety, Bristol Myers Squibb, 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
Expert Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Inspection Findings and Inspectorate Cooperation Trends
Adela Ashie
Principal Regulatory Officer, Food and Drugs Authority, Ghana
International Collaboration: PV collaboration between Ghana, MHRA & MEB
Pat Harding
Sr. Director - GPS Office of the QPPV, Operations/PSMF, Global Patient Safety, Eli Lilly and Company, United Kingdom
Industry Experiences with Inspections - More countries with less experience
Claire Longman, MSc
Expert Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Managing the Perfect Deviation – Regulatory and Industry Perspective
Lauren Kelly
Associate Director, PV Inspection Readiness & Deviation Management, Bristol-Myers Squibb, Ireland
Managing the Perfect Deviation – Regulatory and Industry Perspective