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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
  • 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)

Joanne  Webbe

Industry Perspective on Differences Between Inspections from Various Authorities (EU and Non-EU)

Joanne Webbe

  • Executive Director
  • 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
  • Bristol-Myers Squibb, 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