CDER SBIA & CERSI | FDA Acting Commissioner Dr. Ned Sharpless to Speak at Clinical Investigator Training Course

Clinical Investigator Training Course November 12-14, 2019 | 10th Anniversary

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Announcing Acting Commissioner of Food and Drugs Norman E. “Ned” Sharpless, M.D. Keynote Speaker

Full Agenda

Topics Covered Clinical trial design and analysis, including new trends and key documents such as: protocol, informed consent, investigator’s brochure, health records, and study reports Safety and efficacy requirements Ethical considerations FDA regulatory requirements related to the performance and evaluation of clinical studies Non-clinical, early and advanced clinical studies Roles and responsibilities of the investigator Rationale for Good Clinical Practice (GCP), FDA regulations and inspections Basic statistical principles About this Course This course provides a study of clinical trial principles with in-depth coverage of clinical trial design, issues in safety and efficacy, investigator responsibilities, understanding the investigator brochure, and FDA requirements across Centers. Upon completion, attendees should understand pre-clinical research, clinical trials, and FDA submissions for licensure of medical products.