Drug Evaluation Committee ICH E6(R2) Training Materials.
Clinical Evaluation Subcommittee
July 2018
ICH-E6 (R2) was agreed upon in November 2016, and new initiatives such as Quality Management System (QMS) and Risk Based Approach (RBA) for clinical trials were specified, requiring sponsors and others to introduce new processes. The introduction of a Quality Management System (QMS) and Risk Based Approach (RBA) for clinical trials is now required as a new initiative. Although the trilateral organizations in Japan, the U.S., and Europe have provided guidelines from their respective standpoints, there has not been much understanding or Guideline Workshops on the basic concepts of QMS and RBA, and there has been a demand for such workshops. Therefore, the Clinical Evaluation Subcommittee held a training session to promote understanding of the contents of ICH-E6(R2). In response to requests to use the slides used in the workshop as training materials, we have decided to make them available to the public.
In making the slides available to the public, we have posted precautions for their use and posted the training session materials. We hope that these materials will be of assistance in their implementation in the field.
Attached file: "Precautions for Use" (docx 22KB)