EMEA/ICH Workshop on Viral/Vector Shedding

• Date:
  Mittwoch, 31 Oktober 2007, Ganztägig
• Ort:
  European Medicines Agency, Amsterdam, the Netherlands

Documents

Agenda - EMEA/ICH Workshop on Viral/Vector Shedding

Extract from the Communication Paper of the Gene Therapy Discussion Group Meeting (GTDG)

Regulatory requirements to prevent viral shedding during gene therapy in Japan - Teruyo Arato, Daisuke Maeda, Teruhide Yamaguchi

ESGCT/ICH Workshop on Viral Vector Shedding 1 - Klaus Cichutek

ESGCT/ICH Workshop on Viral Vector Shedding 2 - Klaus Cichutek

Virus Shedding - David Eckland

Vector Shedding and Biodistribution Following Intratumoral Delivery of Adenoviral p53 Gene (ADVEXIN) in Patients with Advanced Non-small Cell Lung Cancer - Toshiyoshi Fujiwara, Noriaki Tanaka

Shedding studies - Didier Guilhem

Evaluation of Seneca Valley Virus Levels Mouse to Man - Paul Hallenbeck

Shedding after in situ rAAV delivery - Review of the literature and 8 years of experience in Nantes in large animal models - Caroline Le Guiner

Current regulatory thinking For viral shedding studies in The European Union - Sharon Longhurst

Regulatory Requirements for Viral Shedding Studies for Gene Therapy Vectors in Switzerland - Andreas Marti

Case Study: Ad2/HIF-1a/VP16: Experience with Viral Shedding & Circulation Testing - Ingrid Boltje

Biodistribution/shedding of AAV1-LPLS447X Vector Sequences after Intramuscular Administration to Lipoprotein Lipase Deficient Patients - Janneke Meulenberg

Shedding of viral vectors during clinical gene therapy - Ellen Schenk

Shedding Studies: Are We Ready for Harmonization? - Stephanie Simek

FDA Perspectives On Viral & Vector Shedding Studies - Daniel Takefman

Nonclinical approaches to study shedding of gene therapy vectors - E.S. van Amersfoort

AAV specific issues pertaining to vector shedding in gene therapy clinical trials - Samuel Wadsworth

Viral Shedding Review of experience of shedding data for in vivo gene therapy - Teruhide Yamaguchi