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Session Chair(s)
Deborah Driscoll, MS
Vice President, MRL Quality Assurance
Merck & Co., Inc., United States
Learning Objective : Identify key findings on GCP inspections from experts from regulatory agenices.
Speaker(s)
Panelist
Jean M. Mulinde, MD
FDA, United States
Associate Director, Division of Clinical Compliance Evaluation, OSI
Panelist
Anabela Marcal, PHARMD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
Panelist
Tomonori Tateishi
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist for Medical Science, Office of Conformity Audit
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