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 Share4Rare Project announces its 1st open call for patient-driven research projects targeted towards patient organisations and researchers in the field of rare diseases to apply for conducting their patient-centred studies within the platform. The call is currently open but will close on July 15th at 17:00 CET. Applicants who are selected can avail the following benefits: Facilitation of communication with patients, their carers…
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…
In the context of EJP RD’s ERN Workshops, a face-to-face workshop on clinical epidemiological research for ERNs titled « Clinical Research: The Basics & Beyond » (consisting of presentations by experts in the field of epidemiology and a feedback session on the research projects of participants) is being organised by Dr. Olaf Dekkers of the Leiden University…