戻る Agenda
Session 1 : GCP Renovation - Will CDM be Renovated as Well?
Session Chair(s)
Michiko Ishida
Office of Non-clinicaland Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Fumiharu Tanaka, MPharm, RPh
Manager, Clinical Operation, SHIONOGI & CO., LTD., Japan
Speaker(s)
Update on ICH E6(R3)
Hiromi Takizawa
Inspector, Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
ICH E6 (R3) with a Focus on Data Governance
Lisbeth Bregnhøj, PhD, MPharm
EC ICH E6(R3) Expert Working Group Member, The Danish Medicines Agency, Denmark
Let's read E6(R3) from the CDMperspective
Osamu Komiyama
CEO, Office Komiyama, Japan
Data Governance: Academic Insights and Practices
Jun Sakurai
Assistant Professor, Center for Innovative Clinical Medicne, Okayama University Hospital, Japan