Development of Advanced Therapy Medicinal Products in Europe 1 March 2018 White papers Advanced Therapy Medicinal Products are innovative and complex medicinal products for which successful development requires a good understanding of the applicable regulatory requirements. This WhitePaper on Advanced Therapy Medicinal Products (ATMP) in Europe, adapted from the article published…
New European Regulation on Clinical Trials, rules and implementation, where are we? 27 February 2018 White papers Clinical Trials (CT) are currently regulated under the Directive 2001/20/EC. The Directive had a positive impact on the safety, ethic and reliability of data from CT. However, limitations were soon evidenced such as a decreased number of CT in…
