2011 PDA Europe Workshop on Advanced Therapy Medicinal Products
Venue: Hilton Hotel Kalastajatorppa
|Event Date/Time: Jun 07, 2011||End Date/Time: Jun 08, 2011|
|Early Registration Date: Apr 11, 2011|
The aim of this workshop, held in collaboration with the Finnish Medicines Agency (Fimea), is to provide a science-based look at the fast growing field of ATMPs. The program will integrate the most recent developments and successes in gene and cell therapies and in tissue engineering.
The PDA Europe Workshop on ATMPs 2011 will be held in Helsinki, Finland on 7-8 June 2011.
This conference will bring together ATMP experts from academia, industry and regulatory bodies around the world. You will have the opportunity to get an update on the entire development of ATMPs, including CMC issues, non-clinical and clinical development, as well as on the recent
regulatory advances concerning ATMPs. The agenda is designed to encourage dialogue between stakeholders about the specific challenges related to the development of ATMPs. The latest achievements relating to the guidance for a risk-based approach, which was introduced into the ATMP legislation in 2009, will be presented and discussed.
The program will cover:
â€¢ Keynote lectures reviewing the hot topics
â€¢ Non clinical and clinical development of gene and cell-based therapies
â€¢ The latest technical advances in ATMPs
â€¢ A breakout technical session for GMP manufacturing
â€¢ The challenges for and the regulatory expectations of GTMP and CBMP development
â€¢ A risk-based approach as part of the marketing authorization process
â€¢ EMA and CAT activities
â€¢ Hospital exemption