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Session Chair(s)
John Poland, PHD
Regulatory Affairs Consultant
Association of Clinical Research Organizations (ACRO), United Kingdom
Learning Objective : Discuss the particular challenges associated with GCP inspection of a risk-adapted clinical trial; Describe how these challenges may be addressed.
Speaker(s)
FDA Point of View
Ann Meeker-O'Connell, MS
Novartis, United States
Executive Director, Monitoring Excellence Head
EMA Point of View
Fergus Sweeney, PHD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force
Industry Point of View
Mike Sobczyk, MSC
Gilead Sciences, Inc., United States
Exec. Director, R&D Quality and Compliance
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