Navigating Changes in China's Registration & Regulatory Process
Wednesday, October 12th, 2:30pm - 3:45pm
To successfully introduce a new product in China requires in-depth knowledge of Chinese regulatory requirements. At the same time, sponsors are increasingly looking to conduct trials simultaneously in multiple countries, putting a premium on a regulatory system that has strong standards that are similar among countries. How are changes in China's regulatory structure supporting increased innovation? How is the SFDA operating in a manner to foster both more rapid drug development to improve public health and internationally simultaneous trials? Are there constraints that make changes to the registration and regulatory process more difficult to achieve? In this session, experienced representatives from multi-national and local Chinese companies will discuss the registration process for products manufactured in China, import licensing issues for products exported to China, and the connotations of these processes for innovative global drug development.
Romi Singh, Executive Director, Regulatory Affairs, Amgen, Inc.
He Bai, Official, Drug Registration Department, SFDA
Wassim Nashabeh, Ph.D, Global Head, Technical Regulatory Policy & Strategy, Genentech, a member of the Roche Group
Romi Singh - Dr. Romi Singh has over 14 years of extensive scientific and management experience in top-tier pharmaceutical and biotechnology companies such as Burroughs/GlaxoWellcome, Merck, and Amgen. His experience spans across the spectrum of drug development-basic research to regulatory/clinical sciences. He is well published and recognized in field of drug metabolism and is an expert on clinical trials and drug registrations in developing countries. Dr. Singh is currently an Executive Director of Global Regulatory & Safety heading the group that supports expansion into new emerging markets in Latin America, Asia, Central & Eastern Europe. He holds an undergraduate degree from St. Stephen’s College, doctorate from the University of Kansas, and has received postdoctoral training from the University of Washington.