平成20年2月18日
独立行政法人医薬品医療機器総合機構
「第2回 PMDA 国際バイオロジクスシンポジウム」の開催にあたり、ご多忙の中、大変多くの方々にご参加いただきまして、御礼申し上げます。当日の講師の方々のプレゼンテーションを掲載いたします。
記
日時
平成20年1月17日(木) 9:30~17:30 (予定) (終了しました)
会場
こまばエミナースホール
住所 |
東京都目黒区大橋2-19-5 |
電話 |
03-3485-1411(代表) |
プログラム
[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 (スライドPDF形式)
Dr. Takao Hayakawa (Senior Advisor, PMDA)
3. European Perspectives on Advanced Therapy Medicinal Products (スライドPDF形式)
Dr. Pierrette Zorzi (Head, Biological Products Evaluation Department, AFSSAPS, France)
4. Implementation of European Legislations for Cell-based Medicinal Products in Germany (スライドPDF形式)
Dr. Ralf Sanzenbacher (Deputy Head, Tissue Engineering, Somatic Cell Therapies, Paul-Ehrlich-Institut)
(lunch)
[PM] 13:30-17:50
5. Immunogenicity of Therapeutic Proteins (スライドPDF形式)
Dr. Steven J. Swanson (Exective Director, Clinical Immunology, Amgen, Inc.)
6. Korean Perspective on Biologics Regulation (スライドPDF形式)
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 (スライドPDF形式)
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 (スライドPDF形式)
Dr. Ruth Wolff (Director, Therapeutics, the Biologics Consulting Group, Inc.)
9. US Industrial Perspective of Remaining Challenges in Biologics Development and Control (スライドPDF形式)
Dr. Anthony Lubiniecki (Vice President, Technology Transfer and Project Planning, Centocor R&D, Inc.)
10. Closing Remarks
Dr. Satoshi Toyoshima (Exective, PMDA)