EATRIS is pleased to announce that researchers are now able to access the Medicines Evaluation Board (MEB) of The Netherlands for informal, early stage regulatory advice via the EATRIS Coordination and Support (C&S) Team, in the context of a pilot collaboration.
The Medicines Evaluation Board assesses and monitors the efficacy, risks and quality of human and veterinary medicinal products.
The MEB have identified that, strategically, their intention is to broaden the scope of scientific advice procedures both towards earlier stages of drug development, e.g. phase I, scientific and regulatory, and towards starters, academic groups, upcoming industry, and other parties that may benefit. The collaboration with EATRIS ERIC will help to achieve this through the sharing of expertise and advices. Areas where potential collaboration is seen covers the provision of expertise in quality, pre-clinical, clinical and pharmacovigilance matters and the possibility for the sharing of regulatory educational resources and IT facilities.
The benefit of this collaboration was summarized by Giovanni Migliaccio, Scientific Director at EATRIS who said, “The agreement between MEB and EATRIS is a great opening and provides the opportunity for many academic groups to learn how to approach a scientific advice with a National Competent Authority structuring their questions in a meaningful way. This would be useful to both and marks a step forward for EATRIS facilitating translational medicine in Europe. We welcome contact from researchers to make use of this exciting new opportunity, offered alongside our usual Regulatory Knowledge and Expertise services.”
If you have an early stage therapeutics development project that could benefit from regulatory advice, please contact the C&S Team at EATRIS.