sábado, 31 de agosto de 2019

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




November 12-14, 2019 | 10th Anniversary
Announcing
Acting Commissioner of Food and Drugs
Norman E. “Ned” Sharpless, M.D.
Keynote Speaker
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.   

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