The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) and the International Society for Cellular TherapyExternal link icon (ISCT) are organising a workshop to discuss how to facilitate the development of advanced therapies on 25 September 2015 in Seville, Spain.
Under the title Challenges and Opportunities for the Successful Development and Approval of Advanced Therapy Medicinal Products (ATMPs), the workshop will bring together academics, developers and regulators for an open discussion on the requirements for a successful development of advanced therapies. Participants will get practical advice on the European authorisation procedure for advanced therapies and the tools and support available to them.
Every year, EMA teams up with an international learned society to organise a workshop in one of the EU Member States. This is an opportunity for the Agency to reach out to academic researchers and small and medium-sized enterprises to explain the regulatory framework for these innovative medicines and the development support the Agency offers.
The workshop will give attendees the opportunity to interact directly with regulators in an open forum discussion and learn more about
• quality development, manufacturing issues and non-clinical testing of ATMPs
• specificities of clinical development of ATMPs
• approval mechanism and EMA support available to ATMP developers
• new EU clinical trial regulation.
