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
Contents of the former Stem Cell Network.NRW website
➤ Translational Research:
➤ Concept
➤ Clinical studies
➤ Further Information
➤ Discover:
➤ What are stem cells?
➤ Types of stem cells
➤ Stem cell applications
➤ Questions and challenges
➤ Ethics and legal aspects
➤ Information for patients
➤ Research approaches
➤ Explore stem cells
➤ For schools
➤ For doctors
➤ Expert referral
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.