Module 1: ICH E6(R2)
This course is particularly directed at government regulatory reviewers and inspectors. It is also applicable for other stakeholders, including investigators, study teams, ethics committee members, research organizations, and sponsors.
The primary learning objective of this activity is to learn key concepts of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) E6(R2) Guideline.
Upon completion of this activity, learners will also be able to:
- Understand the mission of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the relevant research guidance documents it has produced.
- Describe the background and purpose of Good Clinical Practice Guidelines [ICH E6(R1)] and the subsequent revisions for ICH E6(R2).
- Introduce the overarching goals and different parts of ICH E6(R2) and the areas of change.
- Identify to whom ICH E6(R2) applies.
- Demonstrate the applicability of the ICH E6(R2) Good Clinical Practice principles to regulatory reviewers and inspectors.
Multi-Regional Clinical Trials Center of Brigham & Women's Hospital and Harvard, & Partners HealthCare System
[Faculty Information: credentials, associated hospitals, bio information]