Drug Evaluation Committee Quality Control in Drug Development -Examination of Risk Communication
Data Science Subcommittee
December 2023
The Drug Evaluation Committee's Data Science Subcommittee, Continuing Task Force 5-2 in FY2022, focused on risk communication, and examined the current problems and issues related to consent forms, package inserts, risk management plans, and patient guides, which are communication tools between pharmaceutical companies and health authorities, physicians, co-medicals, CRC, and patients. The second section points out the current problems and points to be noted with regard to the consent document, package inserts, risk management plans, and patient guides, which are communication tools between pharmaceutical companies and health authorities, physicians, co-medicals, CRCs, and patients. The consent document is an important communication tool between companies and clinical trial participants, and we devoted particular space to it in considering risk communication issues.
We hope that this deliverable will help to promote mutually better communication among stakeholders, including patients, and further accelerate drug development and the appropriate use of pharmaceuticals.
Japan Pharmaceutical Manufacturers Association
Data Science Subcommittee of the Committee on Drug Evaluation
Task Force 5-2 for FY2021 / Continuing Task Force 5-2 for FY2022
Hironori Sakai (Eisai), Yasushi Komiyama (Pfizer), Hiroshi Koryo (Eisai), Masamichi Ueda (Chugai)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables