Introduction


Regulatory science is a scientific discipline that focuses on the most recent science and technology concerning the development of medicines and innovation. Regulatory Science distinguishes itself from the “classic” academic sciences because questions are mostly generated by government and industry. These questions focus on increasing the efficiency of the regulatory system and improvement of its efficacy, based on scientific facts. Regulatory Science strives to improve methods to determine the benefit-risk balance, transparent decision making, and policy applications within the boundaries of the system itself. Regulatory Science is therefore characterized as a discipline in which not only the hypothesis, but also its applicability are key points. Inherently linked to this description, is that the regulatory system itself is also subject to scrutiny: does the system deliver what society expects? Regulatory science focuses on patient safety, on promoting public health and innovation and is therefore an interdisciplinary research area, which encompasses pharmaceutical science, medical science, biotechnology, law, ethics, and more.


The Medicines Evaluation Board (MEB) and Utrecht University have been collaborating in the field of Regulatory Science for a considerable period of time, pioneering the field of regulatory science and leading research efforts within the European network of regulatory authorities. To achieve this, the MEB works closely together with the European Medicines Agency (EMA) and European academic centers.


The public-private TI Pharma Escher project (2008-2013), in which the MEB collaborated, has delivered a large pool of regulatory science data as well as extensive networks. These research results require valorization and decisiveness for implementation in the field where regulatory science as a discipline stands for.


European initiatives, such as the Innovative Medicines Initiative (IMI) and subsidy programs like Horizon 2020, increasingly require the input of, and collaboration between regulatory authorities, academia and umbrella organizations. Through the shared motto, ‘One Public Health’, RSNN strives to make collaboration between multiple stakeholders feasible. Additionally, the rapid developments within the field of medicine, both innovation and regulation, do not only provide the option, but also make it a necessity to collaborate and share knowledge.


Regulatory Science Network Netherlands (RSNN) sets out to join forces in The Netherlands, and organizing a broad collaboration in the area of Regulatory Science with an eye on Europe.