Aug 27, 2024 Clinical Trial Update in Ireland: New model Clinical Trial Agreement for Tripartite Clinical Trials in Ireland By Kelly Mackey Earlier this summer, the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international originator...
Apr 26, 2023 Single-arm clinical trials: EMA launches consultation By Phillipus Putter In contrast to randomised controlled trials (RCTs), single-arm clinical trials (SATs) are relatively simple by design: a sample of...
Oct 10, 2022 Publication of the English version of the new French Clinical Trial Agreement templates By Johanna Harelimana Alexandre Vuchot Nour Saab The French legislator recently updated the French clinical trial agreement template also called “clinical trial sole agreement”...
Jun 15, 2022 European Commission proposes to change the rules on regulatory data protection for medicines By Marc Martens Sarah Faircliffe Benedicte Mourisse This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...