The National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS) and the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) are hosting a jointly sponsored virtual workshop to explore Regulatory Fitness in Rare Disease Clinical Trials. The virtual workshop will take place over two days on May 16th – 17th. Academic investigators, patient…
Drug development programmes in rare diseases have many challenges, some of which differ from those facing researchers working on common diseases, like the lack of clinical research experts and the scarcity of patients. Moreover, academic sponsors and investigators end up getting involved not only in the scientific aspects of the research but also having to…
The European Medicines Agency’s (EMA) Clinical Trials Information System (CTIS) has gone live as of January 31st. CTIS is the backbone of the Clinical Trials Regulation that will harmonise the assessment and supervision of clinical trials in the European Union. The Clinical Trials Regulation and CTIS will strengthen clinical trials in the EU, ensuring better…
The European Medicines Agency (EMA) is organising a webinar for small and medium enterprises (SMEs) and academia on the Clinical Trial Regulation (Regulation (EU) No 536/2014) and the Clinical Trials Information System (CTIS). The webinar will take place on November 29, 2021 from 09.00 – 13.15 CET. The webinar is being organised as a training event and will present: an…
The European Federation of Pharmaceutical Industries and Associations (EFPIA) is hosting a multi-stakeholder virtual workshop titled « Accelerating Adoption of Complex Clinical Trials in Europe and Beyond » aimed at developing shared solutions for the use of complex clinical trials to optimise drug development in Europe. The online event will take place over two days: October 5th from 14.00 – 19.00 CET and October 6th from 14.00…
Paediatric Clinical Research Infrastructure Network (PedCRIN), a project of ECRIN, announces its PedCRIN Final Event on “Fostering International Paediatric Clinical Research” and invites everyone involved in paediatric clinical trials to join the event. The webinar will take place on June 16, 2021 from 09.30 – 13.00 CET. During the 3.5-hour interactive session focused on the challenges of paediatric multinational clinical trials,…