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 in 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

• Symposium Scenes
•  Quesionnaire Result