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Japanese Pharmacopoeia

PMDA 4th International Symposium on Biologics

  Japanese Web Site

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".

1. Date / Time

Friday, October 9, 2009 / 13:30-17:50(the symposium has already been held)

2. Venue

Address
Nadao Hall
Shin-Kasumigaseki Bldg. 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-0013

3. Theme

The clinical evaluation of the cell/tissue-based products

4. Agenda

PDF 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
(PDF 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
(PDF 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
(PDF 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.
(PDF slide)
15:35-16:05 Contribution of biostatistics to designing clinical trials
Prof. Satoshi Morita, Yokohama City University Medical Center
(PDF 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)
(PDF 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