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Determining Data Integrity: Decoding the Impact of Inspectional Observations
Session Chair(s)
Jean M. Mulinde, MD
Associate Director, Division of Clinical Compliance Evaluation, OSI, FDA, United States
Regulatory authorities rely on inspections of the entities conducting clinical trials to ensure the validity of data and that this data is of sufficient quality to serve as the basis for regulatory decisions. An update on the comparison of EMA and FDA GCP findings of entities that have been inspected by both agencies, will set the stage for this session that will help you understand the impact of inspectional observations on regulators determinations on the adequacy of your data. The session will include discussion of analytic, sponsor, contract research organization, and clinical investigator inspectional findings and why these findings may raise concerns about the validity of data in marketing applications.
Learning Objective : Identify similarities and differences in how the EMA and FDA report on and classify inspectional findings; Describe how inspectional observations impact regulators’ thinking on the validity and integrity of clinical trial data submitted in marketing applications.
Speaker(s)
Anabela Marcal, PHARMD
EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
David C. Burrow, JD, PHARMD
Director, Office of Scientific Investigations, OC, CDER, FDA, United States
Sally Choe, PHD
Director, Office of Generic Drugs, CDER, FDA, United States
Jenn Sellers, MD
Chief, GCP Assessment Branch, FDA, United States
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