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Session 3: Inspections and Audits
Session Chair(s)
Kiernan Trevett, MSC
Quality Policy Lead, Genentech, A Member of the Roche Group, United States
Willemijn van der Spuij, MSC
Executive Director Europe | International - Patient Safety, Bristol Myers Squibb, 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)
Rebecca Webb
Director, Pharmacovigilance Quality Assurance, Abbvie, United Kingdom
Audit Risk-Assessment Process
Amal Arafah, MPH
Medication Safety Specialist , Saudi Food and Drug Authority, Saudi Arabia
Regulators’ Perspective
Pieter Grotenhuis
Senior Inspector for Pharmacovigilance, Health and Youth Care Inspectorate, Netherlands
Regulators’ Perspective
Joanne Webbe
Vice President, Patient Safety, Gilead Sciences International Ltd., United Kingdom
Industry Perspective on Differences Between Inspections from Various Authorities (FDA, Europe, Japan)
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