Drug Evaluation Committee Quality Control in Drug Development -Examination of Risk Communication
Data Science Subcommittee
December 2023
Drug Evaluation Committee, Data Science Subcommittee, Continuing Task Force 5-2, FY2022, is focusing on risk communication, and is investigating the current problems and issues regarding consent forms, package inserts, risk management plans, and patient guides, which are communication tools between pharmaceutical companies, 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
Drug Evaluation Committee Data Science Subcommittee
Task Force 5-2 for FY 2021 / Continuing Task Force 5-2 for FY 2022
Hironori Sakai (Eisai), Yasushi Komiyama (Pfizer), Hiroshi Koryo (Eisai), Masamichi Ueda (Chugai)