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FDA GCP Compliance and Enforcement Updates
Session Chair(s)
Sean Kassim, PhD
Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA, United States
This FDA cross-center session will provide updates on GCP compliance and enforcement activities with a special focus on eClinical technologies in the conduct of clinical trials.
Learning Objective : Describe the FDA's recent GCP compliance and enforcement activities/trends across CBER, CDER, CDRH; Discuss new and applicable guidances, policy and considerations in conducting clinical research; Summarize activities in preparing for an FDA GCP site inspection.
Speaker(s)
CDER Perspective
Sean Kassim, PhD
Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA, United States
CBER Perspective
Bhanu Kannan, MSc
Consumer Safety Officer, Office of Compliance and Biologics Quality, CBER, FDA, United States
CDRH Perspective
Adam C. Donat, MS
Deputy Division Director, Clinical Science and Quality, OPEQ, CDRH, FDA, United States
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