Event categories: CBG

Academia play a key role in drug discovery and development. Indeed, many important advances in clinical practice, including innovative medicines, have their roots in academia. Nevertheless, bringing a drug to the market has proven to be challenging and demanding for academic drug researchers. These challenges have been attributed in part to lacking knowledge of regulatory requirements and skills in navigating the regulatory system. The MEB tries to reach out to academic drug developers, e.g., through its active involvement in training of future Dutch clinical pharmacologists, teaching activities and internships of master students of various Dutch universities, and through its participation in the EU funded Coordination and Support Action on Strengthening Training of Academia in Regulatory Science (CSA STARS; https://www.csa-stars.eu/). The MEB recognizes the value of further advancing the dialogue among academia, regulatory authorities and other stakeholders, such as patient and health-care professional representatives, and health-technology assessment bodies. Building up innovation platforms and experience-sharing networks will foster the timely exchange of information between main players and will facilitate the implementation of academic research findings in clinical practice. This year, the MEB Regulatory Science Day will focus on the current landscape of academic drug development and will address the questions on how to ensure the maximum impact of academic research and its “regulatory readiness”. Through discussions and presentations from invited speakers, we will identify what regulatory-related barriers hamper the translation of novel products or new treatment paradigms initiated in academia, discuss what initiatives have been put in place to close the gap between research and regulation, and reflect on how to make the road of academic drug development, albeit challenging, a rewarding one.

Het hoofdthema van de CBG Collegedag 2021 van de Nederlandse medicijnautoriteit is ‘Balans in roerige tijden’. Vanuit hetgeen we geleerd hebben tijdens de coronapandemie willen we via verschillende invalshoeken naar de toekomst kijken. Welke lessen hebben we geleerd? Maar vooral: wat houden we vast? Voor welke therapeutische gebieden en indicaties in de toekomst zetten we bijvoorbeeld in op versnelde beoordelingen? Welke kansen biedt dit ons als medicijnautoriteit voor de toekomst? We hopen op een inspirerende ochtend, met onderwerpen zoals ethiek, risicocommunicatie en remote clinical trials. Digitale bezoekers en inspirerende prominente sprekers uit het medische, farmaceutische en bestuurlijke veld gaan daar aan bijdragen.