Regulatory Science
As defined by the Medicines Evaluation Board, regulatory science is the science of developing and validating new standards and tools to evaluate and assess the benefit/risk of medicinal products, facilitating sound and transparent regulatory decision making.
It should be noted that regulatory science can also advance knowledge of regulatory systems in general, via analysis of the frameworks used and of their effectiveness.
Regulatory science differs from the 'classical' academic sciences in the sense that questions posed often originate from governmental bodies, industry, medical professionals, patient organizations, and NGOs. These questions focus on increasing the efficiency of the regulatory system and improving its effectiveness on the basis of scientific research results. Regulatory science provides insight into (improved) methods for determining the benefit-risk balance; how transparent approaches to decision-making can be promoted; and how conclusions can be translated into policy.
Regulatory science is therefore characterized as a discipline where not only the hypothesis plays a central role, but also direct application in practice. Implicit in this description is that the regulatory system itself is also part of the research area: does the system deliver what society expects? Regulatory science focuses on patient safety, promoting public health, and innovation, and is thus an interdisciplinary research area with perspectives from, among others, pharmacy, medicine, biotechnology, law, and ethics.
We would love to hear from you!
Submit your ideas, questions or topics for Regulatory Science in the Netherlands and we will be in touch.
