Session 6: Remote Inspections & Audits: Lessons Learnt
Wendy Huisman, PharmD
Willemijn van der Spuij, MSc
Executive Director, WorldWide Patient Safety International, Europe
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.
Industry Perspective on Differences Between Inspections from Various Authorities (EU and Non-EU): Joanne Webbe
Vice President, Patient Safety
Gilead Sciences International Ltd., United Kingdom
Challenges with Virtual/Remote Inspections: Practical Approaches to Organizing Inspections: Helen Fiddes
Head of Country Pharmacovigilance, UK and Ireland
Inspector’s Perspective : Ernesto Vera-Sanchez
Vice President of Regulatory Strategy and Head of GxP consulting services
CATO SMS, Spain
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