Clinical Translation Office
The P-CMR [C] was created to develop research projects of excellence on the use of cells, cell-derived products and tissue-engineered products for therapy, and to help accelerating the clinical translation of Regenerative Medicine strategies. To help researchers navigate the path to clinical translation, the P-CMR[C] created a Regenerative Therapies Clinical Translation Office.
Established in 2020, the Regenerative Therapies Clinical Translation Office is physical located in the Germans Trias i Pujol Campus and aims to provide support to clinicians and basic researchers attempting to translate a regenerative therapy for solid organs into the clinic. The unit provides researchers with support and advice on Good Manufacturing Practice and the legal framework to work with, as well as on addressing the competent regulatory authorities.
From the Regenerative Therapies Clinical Translation Support Office we would like to highlight the importance of approaching this process as a project, planning the design, tasks, and resources of the different phases from the first stages, in the preclinical phase.
The activity of the Clinical Translation Office includes:
- Support to researchers
- Advice on regulatory aspects
- Contacts for GMP experts
- Guidance on AEMPS correspondence
Keywords
Regenerative medicine, clinical translation, ATMP, GMP.
Contact
pgastelurrutia@idibell.cat
