Facilitating the development of advanced therapies

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30/06/2015

Facilitating the development of advanced therapies

Joint workshop with International Society for Cellular Therapy to take place on 25 September 2015 in Seville, Spain

The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) and the International Society for Cellular Therapy (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.

The deadline for registration is 18 September 2015. For further information on the workshop and how to register, please see the ISCT Europe 2015 website. 

About advanced therapies

ATMPs are derived from gene therapy, cell therapy or tissue engineering. Five advanced therapies have been granted an EU-wide marketing authorisation since the creation of the CAT in 2009. This includes the first therapy based on stem cells in 2015. Four advanced therapies are currently under evaluation, including two cell-based, one gene-based and one tissue-based therapy. In 2015, the CAT expects to start evaluating two to three additional medicines.

The CAT is the EMA committee responsible for assessing the quality, safety and efficacy of ATMPs and following scientific developments in the field. Its main tasks are to:

  • assess marketing-authorisation applications for ATMPs;
  • provide scientific input 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. 

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