This course provides an overview of the critical elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to Sponsor Responsibilities and Quality Management of the clinical trial.
This webinar has been specifically designed to help attendees manage a GCP compliant clinical trial. It will provide a background and understanding of the role played by the Sponsor, IRB, Investigators, and the Regulatory Authorities. Attendees will be taken through the key stages of the clinical trial processes.
Areas to be Covered:
The Principles of ICH GCP
Ethics & IRB Responsibilities
Auditing/ Regulatory Authority Inspections
FDA Warning Letters
Who will Benefit:
Clinical Quality Assurance Professionals
Clinical Research Associates
GCP-Focused Regulatory Affairs Professionals