Committee for Advanced Therapies-European Society for Gene and Cell Therapy satellite workshop - Advanced-therapy medicinal products

• Date:
  četvrtak, 27 listopada 2011, Cijeli dan
• Lokacija:
  European Medicines Agency, Amsterdam, the Netherlands

This workshop was the first event organised by the Committee for Advanced Therapies (CAT) in cooperation with a learned society. The workshop brought together industry, academia and regulators to discuss how to progress towards the development of advanced therapy medicinal products. It addressed specific issues related to both gene therapy and cell-based medicinal products.

Documents

Presentation - Cell-based therapy advanced-therapy medicinal products: Manufacturing of cell-based therapy products: common issues and advice

Presentation - Non-clinical development of cell-based medicinal products

Presentation - Cell-based products

Presentation - Cell-based medicinal products for global market: Food and Drug Administration perspectives

Presentation - Manufacturing of gene-therapy products: common issues and advice

Presentation - Non-clinical development of gene-therapy medicinal products

Presentation - Progressing gene-therapy products to the clinic – a platform-based approach

Presentation - Role of European and national regulatory authorities: who advises on what?

Presentation - Role of the European Medicines Agency and national authorities

Presentation - Gene therapy case studies

Presentation - Gene therapy case study: Adenosine deaminase severe combined immunodeficiency

Presentation - cGMP virus manufacture and evolving release tests

Presentation - Cell-based medicinal product - case study 1: Cardioficticell

Presentation - ChondroCelect case study