Advanced Therapies are promised to be one of the main pillars in the future of personalized medicine. Manufacturing and clinical evaluation of pharmaceutical products in this field, so called “Advanced Therapy Medicinal Products” (ATMPs), have to meet regulatory requirements of “Good Manufacturing Practices” (GMP) and “Good Clinical Practices” (GCP).
The professional consultancy enterprise gempex GmbH with core competences in this area sponsored and supported the 4th International Conference on “Strategies in Tissue Engineering” by organizing specific sessions on “ATMP Regulation” and “Future Perspectives in ATMP Regulation” which have focused exclusively on these topics.
Speakers provided views and experiences from regulatory authority, clinical trial management and industry. Keynotes were given by speakers from EMA/Paul-Ehrlich-Institute and the Hannover Clinical Trail Center of Hannover Medical School. More than 40 participants out of the approximately 400 attendees of the conference have taken part in the sessions which were followed by intensive discussions on the aspects of future ATMP regulation. Details of that will be crucial for successful development of new ATMP products in future years.
The conference which is organized by the “Würzburger Initiative Tissue Engineering e. V.” takes place triennial in Würzburg and raises an excellent platform for discussion of further development and future perspectives of the resulting challenges.