ICH Project Workshop "2nd ICH E17 Guideline: General Principles for Planning and Design of Multi-Regional Clinical Trials
August 9, 2022
The Japan Pharmaceutical Manufacturers Association (JPMA),the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) jointly hosted a workshop titled “The Second Workshop on the Concepts of the ICH E17 Guideline: General Principles for the Planning and Design of International Clinical Trials.”
The ICH E17 Guideline was issued in Japan as the “Notice from the Director of the Drug Evaluation and Management Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare, dated June 12, Heisei 30, Regarding the Guidelines on General Principles for the Planning and Design of International Clinical Trials.”
Furthermore, to widely publicize the intent of this notification regarding the ICH E17 Guidelines, a workshop titled “Concepts of the ‘ICH E17 Guidelines: General Principles for the Planning and Design of International Clinical Trials’” was held on December 9, Reiwa 1, co-hosted by the four organizations mentioned above.
This workshop was held because, based on the situation since the workshop in Reiwa 1, it was deemed necessary to further raise awareness. By presenting several specific case examples and conducting explanations, Q&A sessions, and discussions, the workshop aimed to deepen understanding of the ICH E17 Guidelines and promote their implementation to enable more effective and efficient global development.We believe this will contribute to Japan’s smooth participation in international clinical trials and enable the effective and efficient advancement of drug development.
Details regarding the program and other information for this briefing session are available on the PMDA website.