8:30 AM - 5:00 PM
Forum on Regulatory Science and Biomedical Innovations
|Organizers:||Stanford Center for Innovative Study Design and Stanford Center at Peking University|
International Society for Biopharmaceutical Statistics; Institute of Hospital Management, Tsinghua University
Tang Hall, Lee Jung Sen Building - Langrun Yuan, Peking University, Beijing, China (https://scpku.fsi.stanford.edu/docs/visiting-scpku)
Dr. Ruiyi He, MD, Ph.D., Chief Scientist, CFDA Center for Drug Evaluation
Introduction: Over the last decade, we have made significant strides in medical research, disease treatment and improvement of health and well-being of people’s life. Chinese government has placed innovations as a major national strategy for sustainable growth of the country. Out of the concerns for public health and safety, regulatory agencies have the responsibility of implementation of the relevant laws to assure the safety and efficacy of these novel products before they can be used for public. Therefore, how regulatory agencies, the related law and regulations can promote innovation and experiments while perform its duty to protect public health is an important research question.
Program: This forum is for a high-level discussion on this topic by scholars from academia from both China and US, experts from the Chinese Food and Drug Administrations, and R&D experts from biomedical industries. We will have keynote speech sessions and then panel discussion sessions. We will discuss the initiations from regulatory agencies in promoting biomedical innovations and regulatory challenges from regulators, Stanford statisticians on novel statistical designs helping both industry and regulatory agencies to effectively and efficiently evaluate safety and efficacy of emerging medical treatments, the Biomedical Innovators on their challenges facing in translation of their novel inventions to markets and challenges in regulatory pathways for Traditional Chinese Medicine products.
Goals: 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.
Format: Informal discussion on biomedical innovations and role of regulatory science.
Cost: Free registration / by invitation only
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