The First International Symposium on Viral Safety 第1回国際シンポジウム
| 開催日 | January 17, 2005 |
|---|---|
| 会場 | 北里大学 薬学部 コンベンションホール |
Session1 Regulatory Requirements ( Chairs : A. Fuse, J. Magata, A. Möritz )
- FDA Perspective
- Mahmood Farshid (FDA)
- EMEA Perspective
- Patrick Celis (EMEA)
- Industry Perspective
- Annemarie Möritz (Novartis Pharma)
Session 2 Source Material Testing I ( Chairs : Y. Okada, M. Wisher )
- Q-PCR for Virus Detection
- Kurt Brorson (FDA)
- TSE and Prion Detection
- Martin Wisher (BioReliance)
Session3 Source Material Testing II ( Chairs : M. Kohase, T. Kreil )
- Regulatory Approach for Emerging Viruses
- Thomas Kreil (Baxter, PPTA)
- Virus Contamination in Cell Culture
- Barbara Potts (Genentech)
Session4 Testing of Virus Removal/Inactivation I ( Chairs : T. Oba, H. Willkommen )
- Virus Safety Testing
- Hannelore Willkommen (Clearant)
- Robustness Testing
- Herbert Dichtelmüller (Biotest)
Session5 Testing of Virus Removal/Inactivation II ( Chairs : M. Oda, Y. Xu )
- Virus Filtration
- Gail Sofer (Amersham, PDA Task Force Group)
- Matrix Approach
- Yuan Xu (Chiron)
Session 6 Advanced Technology Products ( Chairs : T. Yamaguchi, Y. Satoh )
- Gene Therapy
- Klaus Cichutek (Paul Ehrlich Institute)
Session 7 Discussion and Summary
