Regulatory Science Forum

Regulatory Science is a field looking into developing new tools, standards and approaches to evaluate the efficacy, safety, quality and performance of medicines in order to assess their benefit-risk balance and facilitate a sound and transparent regulatory decision-making. It is the basis for the pharmaceutical regulation to evolve. It can be a fast-moving and exciting research area where for example advances in data analytics, ability to collect the real-world data and turn it into the real-world evidence to support regulatory decision making and rapidly advancing science are transforming the way new treatments are developed. To remain competitive, all regions have to continue to evolve their respective regulatory system to remain at the cutting edge of regulatory science and policy. It also requires collaboration between the regulators, academia, industry and patients. This session explores examples on what major regions and stakeholders are doing to advance their priority topics in regulatory science research and how that contributes to policy making and current practices/regulation.