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Virtual

Sep 07, 2021 7:00 PM - Sep 10, 2021 12:30 AM

(Central Europe Standard Time)

Pharmacovigilance Strategies Workshop

Navigating the changing PV landscape in your daily work. Anniversary edition: 5 years

Session 6: Remote Inspections & Audits: Lessons Learnt

Session Chair(s)

Wendy  Huisman, PharmD

Wendy Huisman, PharmD

Director

Vigifit, Netherlands

Willemijn  van der Spuij, MSc

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)

Joanne  Webbe

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

Helen  Fiddes

Challenges with Virtual/Remote Inspections: Practical Approaches to Organizing Inspections: Helen Fiddes

Head of Country Pharmacovigilance, UK and Ireland

United Kingdom

Ernesto  Vera-Sanchez

Inspector’s Perspective : Ernesto Vera-Sanchez

Vice President of Regulatory Strategy and Head of GxP consulting services

CATO SMS, Spain

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