25 December 2008
22 January 2009
5 February 2009
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17 February 2009
5 March 2009
Pharmaceuticals and Medical Devices Agency
PMDA 3rd International Symposium on Biologics
Pharmaceuticals and Medical Devices Agency (PMDA) has held the "PMDA 3rd International Symposium on Biologics". Thank you for your participations.
Date / Time
Tuesday, 17 February, 2009 / 10:00 - 16:50(the symposium has already been held)
Venue
|
Address |
Yakult Hall |
Theme
Follow-on biologics (Biosimilar)
Agenda
abstract and CV of each speaker| Opening Remarks (Chair: Dr. Toyoshima, PMDA) | |
|---|---|
| 10:00 - 10:10 | Opening Remarks (slide) Dr. Tatsuya Kondo (Chief Executive, PMDA) |
| Keynote Speech (Chair: Dr. Toyoshima, PMDA) | |
| 10:10 - 10:30 | Current status of Japanese Regulation and Development on Biologics. (slide) Mr. Masatoshi Narita (Associate Executive Director, PMDA) |
| Session I (Chair: Dr. Richardson, EMEA & Dr. Arato, PMDA) | |
| 10:30 - 11:05 | Quality, Safety and Efficacy of Follow-on Biologics. (slide) Dr. Teruhide Yamaguchi (Division Head, Division of Biological Chemistry and Biologicals, NIHS) |
| 11:05 - 11:30 | Innovator's perspective of Follow-on Biologics. (slide) Mr. Hideaki Nomura (Manager, Strategic Product Planning Department, Kyowa Hakko Kirin Co., Ltd., JPMA) |
| Session II (Chair: Dr. Yamaguchi, NIHS & Dr. Nyarko, HC) | |
| 11:30 - 12:05 | Regulation of Biopharmaceuticals in the United States of America. (slide) Dr. Keith Webber (Deputy Director, Office of Pharmaceutical Science CDER, FDA) |
| 12:05 - 12:30 | PhRMA Perspective on Follow-on Biologics. (slide) Dr. Marie A. Vodicka (Assistant Vice President, Biologics & Biotechnology, PhRMA) |
| 12:30-13:40 | Lunch |
| Session III (Chair: Dr. Webber, FDA & Dr. Shikano, PMDA) | |
| 13:40 - 14:15 | Biosimilar Medicines in EU. (slide) Dr. Peter Richardson (Scientific Administrator, Quality of Medicines Sector Human Unit Pre-Authorisation, EMEA) |
| 14:15 - 14:40 | Scientific Aspects for the Establishment of Biosimilar Guidelines, the Perspective of EFPIA and EBE. (slide) Dr. Stephan Fischer (SVP Biologics Research and Strategy Pharma Research Penzberg, Roche Diagnostics GmbH, EBE-EFPIA) |
| 14:40 - 15:05 | EGA's perspective on Biosimilar Products. (slide) Dr. Martin Schiestl (Head, Analytics and Pharmaceutical Development Sandoz GmbH, EGA) |
| 15:05-15:20 | Break |
| Session IV (Chair: Mr. Narita, PMDA & Mr. Sato, PMDA) | |
| 15:20-15:55 | Evaluation of similar biotherapeutic products: WHO Guidelines. (slide) Dr. Ivana Knezevic (Scientist, Quality, Safety and Standards Team Immunizations, Vaccines and Biologicals, Department Family and Community Health Cluster WHO) |
| 15:55 - 16:30 | Canadian Approach to the Regulation of Subsequent Entry Biologics. (slide) Dr. Kwasi A. Nyarko (Manager - Special Projects Unit, Policy and Promotion Division, Center for Policy and Regulatory Affairs, Biologics and Genetic Therapies Directorate Health Canada) |
| Conclusion & Closing Remarks (Chair: Mr. Narita, PMDA) | |
| 16:30 - 16:50 | Summary Report. (slide) Dr. Satoshi Toyoshima (Executive Director and Director (Center for Product Evaluation), PMDA) |