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Changing the Mindset Towards Case Quality, Audits, and Inspections: A Practical Approach
Session Chair(s)
Maria C. Koster, PHARMD
Senior Director International Relations, Vigilex, part of the Xendo Group, Netherlands
Alternatives to Traditional Audit Methodologies: Effective Auditing While Risk-Based
Learning Objective : Discuss different approaches taken by various companies and their audit functions in different geographic areas.
Speaker(s)
Drew Kilpatrick, PHD
Vice President, Safety and Pharmacovigilance, INC Research, United Kingdom
Ensuring Standardized Case Quality in Safety and Pharmacovigilance Services through Web-Based Systems
Maria C. Koster, PHARMD
Senior Director International Relations, Vigilex, part of the Xendo Group, Netherlands
Alternatives to Traditional Audit Methodologies: Effective Auditing While Risk-Based
Teiki Iwaoka, PHD, MS
Director, Pharmacovigilance, Clinical Development, Rockhill Consulting, Japan
Struggling with Three Inspectors From Different Worlds: Reality and Idealism
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