European Medicines Agency cooperates with Leipzig University

30-Sep-2013 - Germany

Together with the Translational Centre for regenerative medicine (TRM) of Leipzig University, the European Medicines Agency is organizing a workshop on the approval of regenerative medicine products on 23 October in Leipzig. The expert meeting is expected to attract about 150 international participants, including leading representatives from industry, science and authorities. Topics will span development, production and clinical testing of advanced therapy medicinal products (ATMPs) and thus encompass the complete approval process.

It is only an intensive exchange of expertise between science, industry, clinics and regulatory authorities, that innovative research approaches of regenerative medicine enables to swiftly develop into secure and efficient products for patients. In 2008, the first EU-wide regulatory framework on advanced therapy medicinal products (ATMPs) entered into force. In this respect, the Committee for Advanced Therapies (CAT) of the European Medicines Agency is of central importance. The role of the Committee shall be to evaluate the applications for authorisation and to keep evolving the field of regenerative medicine under permanent review. Jointly initiated by the CAT and the TRM Leipzig, a one-day workshop now gives all interest groups the opportunity to discuss the complex and dynamic regulatory environment of cell and tissue-based products. Common concern of both organizers is to strengthen the dialogue between the regulatory authorities and all stakeholders concerned, thus pave the way for early and targeted marketing approval for advanced medicinal products in a long term.

For the first time, the Committee for Advanced Therapies hosts the regulatory workshop in cooperation with an application-oriented research centre in recognition of the trailblazing research on developing ATMPs in academic surroundings. Professor Frank Emmrich, president of the parallel taking place World Conference on Regenerative Medicine, is pleased with the partnership: „The collaboration with the European Medicines Agency is a great distinction for the TRM“, says the TRM director. „With the workshop, we are in the fortunate position to be able to offer our international guests expected to take part in the World Conference the rare opportunity to directly communicate with experts, who are actively engaged in current regulatory processes.“

https://www.bionity.com/en/news/145165/european-medicines-agency-cooperates-with-leipzig-university.html