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PMDA 5th International Symposium on Biologics

Sep 6, 2010
August 20 2010
July 23 2010
June 24 2010
Pharmaceuticals and Medical Devices Agency

PMDA 5th International Symposium on Biologics

Pharmaceuticals and Medical Devices Agency (PMDA) has held the "PMDA 5th International Symposium on Biologics".

Date / Time

Thursday, August 26, 2010 / 13:30-17:35 (the symposium has already been held)

Venue

Address

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

Theme

Quality and non-clinical evaluation of cell/tissue-based products

Agenda

abstract and CV of each speaker

Opening Remarks

13:30 - 13:35 Opening Remarks
Dr. Hideo Utsumi, Executive Director and Director, Center for Product Evaluation, PMDA

Session I    Chair: Dr. Shikano, PMDA & Prof. Aoi, Kyoto Univ.

13:35 - 14:05 European perspectives on quality and non-clinical evaluation of cell based medicinal products
Dr. Bettina Klug, Advanced Therapy Medicinal Products, Tissue Preparations, Paul-Ehrlich-Institute PEI
(slide)
14:05-14:35 France legal & regulatory framework for cell/tissue-based products and its relationship with the European system
Dr. Pierrette Zorzi, Head, Biological Products Department, AFSSAPS
(slide)
14:35-14:50 Break

Session II    Chair: Dr. Tominaga, PMDA & Mr. Takayama, PMDA

14:50 - 15:20 PMDA's perspective on quality and non-clinical evaluation of cell/tissue-based products
Dr. Mayumi Shikano, Office Director, Office of Biologics II, PMDA
(slide)
15:20 - 15:50 Researcher's perspective on quality and non-clinical evaluation of cell/tissue-based products
Prof. Takashi Aoi, Department of Regulatory Science, Center for iPS Cell Research and Application
(CiRA) Kyoto University (slide)
15:50 - 16:20 FDA's perspective on quality and non-clinical evaluation of cell/tissue-based products
Dr. Raj K. Puri, Director, Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene
Therapies, CBER/ FDA (slide)
16:20-16:40 Break

Panel Discussions    Chair: Dr. Miyake, PMDA

16:40 - 17:30 Dr. Raj K. Puri, Dr. Bettina Klug, Dr. Pierrette Zorzi, Dr. Mayumi Shikano, Prof. Takashi Aoi

Closing Remarks

17:30 - 17:35 Closing Remarks
Dr. Tatsuya Kondo, Chief Executive, PMDA

Overall Chair: Dr. Tadano, PMDA