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APPROVAL PROCESS AND EXPERIENCE TO DATE/CHALLENGES AND SUCCESSFUL OUTCOMES OF ATMP DEVELOPMENT
Session Chair(s)
Beatriz Silva Lima, PHARMD, PHD
Director of FFUL, Faculty of Pharmacy
University of Lisbon, Portugal
The progress on gene and cell therapies from regulation implementation will be addressed from European perspective. The rapid knowledge evolution will be illustrated with examples of products history from their research until their current stage.
Learning Objective : -be updated on the scientific advances on cell therapy -be updated on the the scientific advances in gene therapy, including new vectors and vector safety -acknowledge the importance of following regulatory requirements for the development of new products -acknowledge the need to interact with regulators
Speaker(s)
An Overview to MAA Process for ATMPs and CAT Experience from Five First Years
Patrick Celis, PHD
European Medicines Agency, Netherlands
Scientific Administrator
Commercially Viable Options for ATMP Manufacture
Klaus Maleck
TETEC AG, Germany
CEO
International Regulatory Co-Operation for ATMPs
Liz Anne Gillham-Eisen, BSN
Health Canada, Canada
Senior Policy Advisor / Unit Manager