PMDA 2nd International Symposium on Biologics
18 February 2008
Pharmaceuticals and Medical Devices Agency
Thank you very much for having attended the PMDA 2nd International Symposium on Biologics. We are pleased that the symposium was successful with many people. The following are slides from the presentations given by the speakers on the day.
1. DATE / TIME
9:30-17:30 , Thursday, January 17, 2008(the symposium has already been held.)
2. Venue
Komaba Eminence
- Address
- 2-19-5, Ohashi, Meguro-ku, Tokyo 153-0044
5 minutes on foot from Komaba-Todaimae station (Keio Inokashira Line) - Phone
- +81-3-3485-1411 (Key number)
+81-3-3485-1416 (Hall)
3. Speakers
- [AM] 9:30-12:00
- 1. Opening Remarks
Mr. Shuuichi Kishida (Senior Executive Director, PMDA) - 2. Current Topics in Japan with Respect to Evaluation and Control of Biotechnology Products （
slide pdf）
Dr. Takao Hayakawa (Senior Advisor, PMDA) - 3. European Perspectives on Advanced Therapy Medicinal Products （slide pdf）
Dr. Pierrette Zorzi (Head, Biological Products Evaluation Department, AFSSAPS, France) - 4. Implementation of European Legislations for Cell-based Medicinal Products in Germany （slide pdf）
Dr. Ralf Sanzenbacher (Deputy Head, Tissue Engineering, Somatic Cell Therapies, Paul-Ehrlich-Institut) - (lunch)
- [PM] 13:30-17:50
- 5. Immunogenicity of Therapeutic Proteins （slide pdf）
Dr. Steven J. Swanson (Exective Director, Clinical Immunology, Amgen, Inc.) - 6. Korean Perspective on Biologics Regulation （slide pdf）
Dr. Seunghwa Hong (Division Director, Blood Products Team, Biologics Headquarters, Korea Food & Drug Administration, Republic of Korea) - 7. Canadian Perspective on Biologicals Regulation; and Review of Gene Therapy Activity （slide pdf）
Dr. Anthony Ridgway (Senior Regulatory Scientist, Office of the Director Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, Biologics and Genetic Therapies Directorate Health Products and Food Branch Health Canada, Canada) - 8. US Regulatory Perspectives on Biologics Evaluation and Control （slide pdf）
Dr. Ruth Wolff (Director, Therapeutics, the Biologics Consulting Group, Inc.) - 9. US Industrial Perspective of Remaining Challenges in Biologics Development and Control （slide pdf）
Dr. Anthony Lubiniecki (Vice President, Technology Transfer and Project Planning, Centocor R&D, Inc.) - 10. Closing Remarks
Dr. Satoshi Toyoshima (Exective, PMDA)