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 |
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