The First International Symposium on Viral Safety

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