Date: Thursday, February 15, 2007
Venue: Hotel & Hall Komaba-Eminence in Tokyo
Chair: Mr. Katsutoshi Tanaka, Office Director, Office of Biologics, PMDA
Dr. Takao Hayakawa, Senior Advisor, PMDA
| TimeTable | |
|---|---|
| 9:30 - 9:40 | Opening Remarks Mr. Akira Miyajima, Chief Executive, PMDA |
| 9:40 - 11:00 | Some Aspects of Development, Evaluation and Control of Biologics in Japan (slide) Dr. Takao Hayakawa, Senior Advisor, PMDA |
| 11:00 - 11:50 | Continuous Cell Line Substrates for the Manufacture of Biological Products (slide) Dr. John Petricciani, Immediate Past President, International Association for Biologicals (IABs) |
| Lunch | |
| 13:10 - 14:00 | European Perspectives on Regulation for Biologics (slide) Prof. Dr. Jean-Hugues Trouvin, Director of AFSSAPS, Chair of Bio Working Group of CHMP, EMEA |
| 14:00 - 14:50 | US Perspective on Biological Regulation (slide) Dr. Christopher Joneckis, Senior Advisor for Chemistry Manufacturing and Control Issues, Office of the Center Director, CBER, FDA |
| 14:50 - 15:40 | Advanced Therapy Medicinal Products: Present and Future Regulation n the EU (slide) Prof. Dr. Klaus Cichutek, Vice President, Paul Ehrlich Institut |
| Break | |
| 16:00 - 16:50 | The Biotech Industry: Past, Present and Future (slide) Dr. Robert Garnick, Senior Vice President, Regulatory, Quality and Compliance, Genentech, Inc. |
| 16:50 - 17:40 | Global Industrial Perspective of Novel Biologicals Development (slide) Dr. Anthony Lubiniecki, Vice President, Technology Transfer & Project Planning, Centocor |
| 17:40 - 17:50 | Closing Remarks Dr. Satoshi Toyoshima, Executive, PMDA |