In the dynamic world of clinical trials, staying up to date with the latest regulations and tools is of utmost importance to sponsors. Recent developments from the Clinical Trials Transformation Group (CTCG) and the European Commission provide sponsors with valuable guidance and resources for adaptation to the Clinical Trials Regulation and the Clinical Trials Information System (CTIS).
The CTCG has released an updated version of the Best Practice Guide and a cover letter template form. These resources on the CTCG webpage provide useful insights and best practices for navigating the regulatory process.
The European Commission has released an updated version of the CTR Quick Guide for sponsors. This guidance provides important information, including guidance on the submission of the Investigational Medicinal Product Dossier (IMPD-Q) when manufacturing takes place at a designated care setting or at a clinical trial site in an additional Member State.
The European Medicines Agency (EMA) and the European Medicines Regulatory Network (EMRN) continue to offer training sessions and information sessions to support CTIS users. These events are broadcast live, and video recording are available at Clinical Trials Information System Webinar: Second Year of Transition | European Medicines Agency (europa.eu).