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.