Forum on Regulatory Science and Biomedical Innovations —Real-World Evidence in Biomedical Product Development and Regulatory Science

Over the last decade, significant strides have been made in medical research, which leads to great improvement in human health. During this period, Chinese government has made important progress in promoting and managing medical innovations. Chinese FDA is now a formal agency member of the international council for harmonisation of technical requirements for pharmaceuticals for human use (ICH). With further integration of China into the global pharmaceutical research and development, how government regulatory agencies, the related law and regulations can promote industry innovation, while enhance their accountability and responsibility remains an important question. This forum is organized to address this need.

This forum provides a platform for high-level discussions on this topic by Chinese and US scholars from academia, experts from the Chinese Food and Drug Administrations, and R&D experts from biomedical industries. On June 7-8, 2019, the forum will host keynote speech sessions, invited talks, and panel discussion sessions. With collaborations from Chinese evidence based medicine association, we will discuss methods and policy related to monitoring drug safety, novel clinical trial design, and applications of modern statistical, AI and machine learning methods in drug development. On June 6, 2019, a one-day short course will be offered on "Statistical Methods for Medical Product Safety Evaluation."

Through this brainstorming and exchange, we want to identify research priorities and collaborative mechanisms for international scholars from academia, regulatory agencies and industry working together to promote biomedical innovations in an efficient and orderly manner.