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How Will Risk-adapted Clinical Trials Be Inspected?
Session Chair(s)
John Poland, PhD
Regulatory Affairs Consultant
Association of Clinical Research Organizations (ACRO), United Kingdom
The particular challenges posed by GCP inspection of a risk-adapted clinical trial, and how they may be addressed, will be analyzed and discussed in terms of regulatory agency expectations and practical examples.
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
FDA, United States
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
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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