Below you can find a compilation of documents relevant for translational research:
➚ Guidelines for Stem Cell Research and Clinical Translation, International Society for Stem Cell Research (ISSCR) ➚ Advice for drug development (e.g. regarding regulatory requirements) at the Paul-Ehrlich-Institut ➚ Decision tree ATMP classification ➚ Medicinal Products Act (translation of Arzneimittelgesetz – AMG) ➚ Guidelines on Human Cell-based Medicinal Products, European Medicines Agency (EMA) ➚ Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products, EMA
This information on the Stem Cell Network.NRW are also available in German → here. Diese Informationen zum Stammzellnetzwerk.NRW stehen → hier auch auf Deutsch zur Verfügung.