Further information

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

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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.

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