Clincal Translation Resources

We have recently published an article that summarizes important information for clinical translation for independent researchers working on regenerative approaches. It covers several areas such as the types of Advanced Therapy Medicinal Products (ATMP), some insights on the preclinical phase in terms of the characterization of the product and the animal experiments, the adaptation of the product to the regulatory and legal requirements for its transfer to the clinic complying with the GMP standards (good manufacturing practice) and product scalability. In addition, the article also reviews the different documents necessary for the approval of the product for both the ethics committee and the corresponding regulatory agency (the Spanish Agency for Medicines and Health Products-AEMPS- in our case). And the need for the collaboration of multidisciplinary teams to be able to cover all the necessary areas of knowledge. You can read the article in the following link.
You can access the paper here:
Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience. [pdf]
Gastelurrutia P, Prat-Vidal C, Vives J, Coll R, Bayes-Genis A, Gálvez-Montón C.
Front. Cardiovasc. Med., (2021)

Map of Regenerative Medicine Efforts in Catalonia

As a result of the Expression of Interest in Collaborative Projects in Regenerative Medicine launched in 2019 and the feedback of the P-CMR[C] Advisory Board, we have elaborated a Map of the efforts in translation in Regenerative Medicine in Catalonia, under constant update. Please, feel free to contact us if you are working on regenerative medicine and your group is not listed, by sending an email to pgastelurrutia@idibell.cat, indicating Map of Regenerative Medicine in the subject line.
You can download the last updated version here:
Map of Regenerative Medicine Efforts in Catalonia. [pdf]
© P-CMRC 2009-2022 | Legal Notice |
Privacy Policy | Design