ICH Project Workshop "The 2nd ICH E17 Guideline: General Principles for the Planning and Design of Global Clinical Trials
Japan Pharmaceutical Manufacturers Association (JPMA), European Federation of Pharmaceutical Manufacturers and Associations (EFPIA), Pharmaceutical Research and Manufacturers of America (PhRMA), and Pharmaceuticals and Medical Devices Agency (PMDA) jointly hosted a
workshopon August 9, 2022
entitled "The 2nd ICH E17 Guideline: General principles for planning and designing global clinical trials". The workshop was co-hosted by PhRMA and the Pharmaceuticals and Medical Devices Agency (PMDA).
The ICH E17 Guideline was issued in Japan on June 12, 2008 as "Guideline on General Principles for Planning and Design of Global Clinical Trials" by the Director, Drug Evaluation and Management Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare.
In addition, a workshop titled "ICH E17 Guideline: General Principles for Planning and Design of Global Clinical Trials" was held on December 9, 2048, jointly hosted by the above four organizations in order to disseminate the purpose of the ICH E17 Guideline.
The workshop was held to deepen understanding of the ICH E17 Guideline and to promote more effective and efficient global development through explanations, question-and-answer sessions, and discussions, including some specific examples, as it was considered necessary to further disseminate the Guideline in light of the situation since the workshop held in 2028. The purpose of the meeting was to promote further understanding of the ICH E17 Guidelines and to promote the application of these Guidelines for more effective and efficient global development. We believe that this will contribute to Japan's smooth participation in global clinical trials and effective and efficient drug development.
For more details, including the program of this meeting, please visit the PMDA website.