Clinical Trials, GCPs, Regulations and Compliance for Drugs, Biologics and Medical Devices and Clinical Submissions

This course discusses the purpose of Good Clinical Practices as well as their historic evolution until today. Also, it presents an overview of clinical trials for Drugs, Biologics, and Medical Devices, their different phases, their monitoring and auditing process, and the responsibilities of the various parties involved. The course outlines all the premarket submission requirements in relation to clinical data.

At the end of this course, students will be able to review and understand clinical studies’ elements, develop informed consent, and submit premarket clinical data in a proper format.

Learning Points:

• Good Clinical Practice and Good Laboratory Practice Overview
• Clinical Trial Phases for Drugs and Biologics
• Clinical Trial Overview for Medical Devices
• Informed Consent
• Roles and Responsibilities of Institutional Review Boards (IRBs), Sponsors, CROs, Principal Investigators
• Clinical Trial Monitoring
• Clinical Investigation Plan (Protocol)IND Submissions and IND Types for Drugs and Biologics and Other Regulatory Submissions for Medical Devices