×
Back to Agenda
Session 5 - Gene Therapy Products and Procedures for the Cartagena Law
Session Chair(s)
Teruhide Yamaguchi, PHD
Professor
Nihon Pharmaceutical University / Kanazawa-Instituite of Technology, Japan
Masafumi Onodera, MD, PHD
Director, Center of Gene Cell Therapy Promotion,
National Center for Child Health and Development, Japan
Speaker(s)
Operation and Issues of Cartagena Law in Japan
Masafumi Onodera, MD, PHD
National Center for Child Health and Development, Japan
Director, Center of Gene Cell Therapy Promotion,
Environmental Assessments and Shedding Studies for Gene Therapy Products in the US and Japan
Teruhide Yamaguchi, PHD
Nihon Pharmaceutical University / Kanazawa-Instituite of Technology, Japan
Professor
Clinical Trials with Vaccines based on Genetically Modified Organisms in Europe and USA
Myra Widjojoatmodjo, PHD
Janssen Vaccines & Prevention B.V., Netherlands
Director
Points to Consider for Environmental Risk Assessment of the Use of Living Modified Organisms; PMDA Perspectives on Type 1 Use Approval under “Cartagena Law”
Kazunobu Oyama, PHD
Daiichi Sankyo Company, Limited, Japan
CMC Regulatory Affairs, Director
Have an account?