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Session 6: Remote Inspections & Audits: Lessons Learnt
Session Chair(s)
Wendy Huisman, PharmD
Director
Vigifit, Netherlands
Willemijn van der Spuij, MSc
Executive Director, WorldWide Patient Safety International, Europe
Switzerland
This session will focus on recent experiences and news from inspections. 3 areas will be addressed. The first: An MAH perspective on different HA inspection experiences, the second: a very practical approach to organizing remote inspections and, the third: a HA perspective on inspections and recent and current hot topics. In addition, Q&A time will allow for the audience to engage with the speakers.
Speaker(s)
Industry Perspective on Differences Between Inspections from Various Authorities (EU and Non-EU)
Joanne Webbe
Gilead Sciences International Ltd., United Kingdom
Vice President, Patient Safety
Challenges with Virtual/Remote Inspections: Practical Approaches to Organizing Inspections
Helen Fiddes
United Kingdom
Head of Country Pharmacovigilance, UK and Ireland
Inspector’s Perspective
Ernesto Vera-Sanchez
CATO SMS, Spain
Vice President of Regulatory Strategy and Head of GxP consulting services
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