9th DIA Cell and Gene Therapy Products Symposium in Japan

Development of Next-Generation Cell and Gene Products - Issues in Development of Existing Products and Prospects for Practical Application of Next Generation Products -

戻る Agenda

Session 2 : CMC Regulatory Affairs Professionals - a Key Player for Successful Development of Cell and Cene Therapy Products -

Session Chair(s)

Ryutaro Hirasawa

CMC Regulatory Affairs, Associate Director

Daiichi Sankyo Co., Ltd., Japan

Akiyo Fujikawa

Senior Director of Regulatory Affairs

Aurion Biotech Japan, LLC, Japan

Speaker(s)

Communication with Regulatory Authorities on CMC-related Issues for Regenerative Medical Products

Kenichiro Maeda, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Office of Cellular and Tissue-based Products

The Role of CMC Regulatory Personnel Required for Regenerative Medicine Development in Academia

Masao Sasai, PhD

Osaka University, Japan

Department of Medical Innovation, Specially Appointed Assistant Professor

Points to Note for CMC Regulatory Strategy in New Modality Drug Development

Rou Irisawa

Irisawa Consulting, LLC., Japan

Exectuive Member

Efforts for Expertise Cultivation of CMC Regulatory Affairs Professionals

Masayuki Sato, PhD

Daiichi Sankyo.Co.,Ltd, Japan