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Think Like a Regulator: Evaluating Trial Integrity
Session Chair(s)
Ann Meeker-O'Connell, MS
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
FDA, United States
Are you involved in auditing clinical trials, and working through applying the risk-based approach advocated by ICH E6 R2 to your audit program? This workshop will help you understand how review staff from international regulatory authorities evaluate non-compliance and its impact on trial and marketing application integrity. As one of eighty participants, you will learn how regulators determine what clinical trial data and processes are critical to the credibility of conclusions made based on clinical trial data and how this translates to their review of inspection findings . You’ll get hands-on practice discussing real-life inspectional finding, and you’ll have the opportunity to share how you would advise the regulatory review team on the impact to quality. You leave with tangible approaches you can take home to your company.
Learning Objective : Describe how regulators determine what is critical to quality for a clinical trial and where risks may materialize; Apply this approach through reviewing inspection observations and evaluating their relevance to the credibility of clinical trials
Speaker(s)
Facilitator
Hitoshi Ozawa, MPharm
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
GCP Inspector, Office of Non-Clininical and Clinical Compliance
Facilitator
Jean M. Mulinde, MD
FDA, United States
Associate Director, Division of Clinical Compliance Evaluation, OSI
Facilitator
Anabela Marcal, PharmD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
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