October 28 2009
October 6 2009
September 15 2009
September 08 2009
Pharmaceuticals and Medical Devices Agency
PMDA 4th International Symposium on Biologics
Pharmaceuticals and Medical Devices Agency (PMDA)has held the "PMDA 4th International Symposium on Biologics".
Date / Time
Friday, October 9, 2009 / 13:30 - 17:50(the symposium has already been held)
Venue
|
Address |
Nadao Hall |
Theme
The clinical evaluation of the cell/tissue-based products
Agenda
abstract and CV of each speaker
Opening Remarks & Keynote Speech Chair: Dr. Toyoshima, PMDA
| 13:30 - 13:35 | Opening Remarks Dr. Tatsuya Kondo, Chief Executive, PMDA |
| 13:35 - 13:50 | Keynote Speech Dr. Yoshinobu Hirayama, Associate Executive Director, PMDA (slide) |
Session I Chair:Mr. Takayama, PMDA & Dr. Tominaga, PMDA
| 13:50 - 14:25 | Clinical evaluation of cell based medicinal products - Europeans' perspective Dr. Bettina Klug, Paul-Ehrlich-Institute (slide) |
| 14:25 - 14:55 | PMDA's perspective on the clinical evaluation of cell/tissue-based products Dr. Kenichi Yanagi, Deputy Review Director, Office of Biologics II, PMDA (slide) |
| 14:55 - 15:05 | Break |
Session II Chair:Dr. Klug, PEI & Dr. Shikano, PMDA
| 15:05 - 15:35 | J-TEC's perspective: The clinical development of the autologous cell/tissue-based medicinal products Dr. Kenichiro Hata, Managing Director, R&D Department, Japan Tissue Engineering Co.,LTD. (slide) |
| 15:35 - 16:05 | Contribution of biostatistics to designing clinical trials Prof. Satoshi Morita, Yokohama City University Medical Center (slide) |
| 16:05 - 16:20 | Break |
Panel Discussions Chair:Dr. Hirayama, PMDA
| 16:20 - 17:20 | Dr. Bettina Klug、Dr. Yanagi, Dr. Hata、Prof. Morita (Specific comment:Dr. Akifumi Matsuyama, Director, Department of somatic stem cell therapy, Institution of biomedical research and innovation laboratory, Foundation for Biomedical Research and Innovation) (slide) |
Closing Remarks Chair; Dr. Hirayama, PMDA
| 17:25 - 17:30 | Summary Report Dr. Satoshi Toyoshima, Executive Director and Director, Center for Product Evaluation, PMDA |
Overall Chair: Dr. Tadano, PMDA