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Pharmacovigilance Strategies Workshop
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
- Bristol-Myers Squibb, 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
- Executive Director
- 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
- Bristol-Myers Squibb, United Kingdom
Inspector’s Perspective
Ernesto Vera-Sanchez
- Vice President of Regulatory Strategy and Head of GxP consulting services
- CATO SMS, Spain
