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- PMDA 3rd International Symposium on Biologics
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22 January 2009
5 February 2009
13 February 2009
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.
1. Date / Time
Tuesday, 17 February, 2009 / 10:00-16:50(the symposium has already been held)
2. Venue
- Address
- Yakult Hall
1-1-19 Higashi-Shinbashi, Minato-ku, Tokyo 105-8660
Five minutes walk from Shinbashi station (JR Yamanote line,Tokyo Metro Ginza line and Toei Asakusa line).
3. Theme
Follow-on biologics (Biosimilar)
4. 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) |