European Medicines Agency and German Society for Transfusion Medicine and Immunohaematology to co-organise workshop on advanced therapies
The European Medicines Agency's Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and Immunohaematology (DGTI) in collaboration with the German Stem Cell Network (GSCN) are organising a workshop to strengthen dialogue between the CAT and the developers of advanced-therapy medicinal products (ATMPs), facilitating ATMP development and access to regulatory tools.
Entitled 'How to bring cell-based medicinal products successfully to the market', the workshop will take place at the Maritim Internationales Congress Centrum in Dresden, Germany, on 11 September 2014 as a satellite symposium of the DGTI Conference 2014.
The aim of the workshop is to provide ATMP developers, in particular academics and small companies, practical advice on the European authorisation procedure for ATMPs and the tools and support available to them.
“This is the third workshop that the CAT has co-organised with a learned society to promote development of ATMPs and raise awareness of the regulatory tools available,” explains Dr Paula Salmikangas, the Chair of the CAT. “Non-commercial sponsors and SMEs are the main developers of ATMPs. The aim of these workshops is to further support the translation of innovation into successful developments in the interest of patients.”
The workshop will give attendees the opportunity to:
- learn about the development and authorisation of cell-based ATMPs in the European Union;
- learn about the role of the CAT and the support provided by European Medicines Agency (EMA) and the CAT to ATMP developers;
- understand the criteria that CAT applies for the classification of ATMPs;
- hear about CAT's considerations and recent interactions with experts on cell-based therapies for cardiac repair;
- interact directly with the regulators in an open forum discussion.
For further information on the workshop and how to register, please see the DGTI Conference 2014 website.
About the CAT
ATMPs are derived from gene therapy, cell therapy or tissue engineering.
The CAT is the committee at the EMA responsible for assessing the quality, safety and efficacy of ATMPs and following scientific developments in the field. Its main tasks are to:
- review marketing-authorisation applications for ATMPs;
- provide support to the Agency's Scientific Advice Working Party for all scientific advice for ATMPs;
- provide scientific recommendations on the classification of medicines as ATMPs;
- evaluate early quality and non-clinical data in the framework of an ATMP certification.