On October 11, 2012, two FP7-funded Research Consortia, CONTRACT (Consent in a Trial and Care Environment) and Academic GMP, held a Joint Conference in Brussels entitled "The Impact of EU Legislation on Therapeutic Advance." Academic researchers including stem cell transplant physicians and cell therapy specialists, legal advocates and representatives from industry, regulatory authorities and patient advocacy groups met with members of the European Parliament and the European Commission. This article summarizes important points of discussion and detailed proposals for improvement.
Keywords: ATMP; European Union; clinical trial; informed consent.
Copyright © 2013 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.