Full course description
Regulatory science concerns “the development and use of tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality with the overarching objective of improving global health”. With the increasing role of regulatory agencies as knowledge stewards and broker's (data sets), comes the expansion of the regulatory mission, from solely protection, to the protection and promotion of the health of the public.
Innovation to address the 21st century’s evolving regulatory landscape, in the context of new technologies, new understanding of diseases and a sharpened lens on safety -- is an exciting new area of science, one that requires a new generation of trained regulatory experts and professionals in academic, government, industry and public health sectors. Moreover, innovations in drug development offer great opportunities for treatments to address unmet medical needs worldwide. Corresponding innovations in regulation of drug products are essential to evaluate their efficacy and safety and provide a more efficient path to ensure access for patients who need them.
The aim of this course is to provide you with information needed to understand the most important health practice and product regulation issues in the US and abroad from the perspective of current regulatory standards, their standards for evidence and the role of innovation in regulatory science. Building regulatory capacity is important for the US as well as the regional context.
Students completing this course will receive a Certificate of completion from the UC Berkeley School of Public Health.