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Session 3: Inspections and Audits
Session Chair(s)
Kiernan Trevett, MSc
Principal Quality Lead, PDQ Quality Assurance Process GVP
Genentech, A Member of the Roche Group, United States
Willemijn van der Spuij, MSc
Executive Director, WorldWide Patient Safety International, Europe
Switzerland
Audits and inspections play an important role in pharmacovigilance activities. Managing multiple audits and inspections brings new challenges for stakeholders. This session will explore different inspectors’ perspectives on inspection topics and trends and will include industry experiences related to managing inspections from different authorities. In addition the session will look at different approaches to risk assessments for audit planning and how to handle and manage multiple audit requests. An interactive part to the session will allow the audience to share their experiences and engage with regulators and industry experts.
Speaker(s)
Audit Risk-Assessment Process
Rebecca Webb
Abbvie, United Kingdom
Director, Pharmacovigilance Quality Assurance
Regulators’ Perspective
Amal Arafah, MPH
Saudi Food and Drug Authority, Saudi Arabia
Medication Safety Specialist
Regulators’ Perspective
Pieter Grotenhuis
Health and Youth Care Inspectorate, Netherlands
Senior Inspector for Pharmacovigilance
Industry Perspective on Differences Between Inspections from Various Authorities (FDA, Europe, Japan)
Joanne Webbe
Gilead Sciences International Ltd., United Kingdom
Vice President, Patient Safety
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