Where
This is an online event. Please click on the Register Now! button to register for the webinar.
Contact
Aprille Walker, Business DevelopmentFountain Medical Development (FMD)
414-803-6456
aprille.walker@fountain-med.com
Leverage the Regulatory Changes in China to Accelerate Global Drug Development Program
The regulatory regimes in China has been undergoing a significant overhal. These changes aiming to align the China system to the ICH standerds is causing confusion and misunderstanding. To take full advantage of the new system in China, overseas compaines must plan early to include China in their global development plan to accelerate their product development cycle.
Our industry experts will explore the recent regulatory reforms in China including the new regulations on the acceptance of foreign data by the China National Drug Administration (CNDA) formerly the cFDA. They will focus on the impact on the biopharma industry. Audience will learn how to take full advantage of the reform to accelerate global development.
Dr. Dan Zhang, Executive Chairman of FMD
Dan has over 20 years of drug development experience. Before founding FMD in 2007, he was Head of Clinical Drug Development at Sigma-Tau, an Italian drug maker. Prior to that Dan was a Vice President at the Quintiles Transnational Corp. and the Chairman of the Board of Quintiles' Greater China business.
Dan is deeply involved in drug development and regulatory reform in China. He has been a long time CFDA advisor, helping the agency modernize its regulations. He has served on the Agency’s New Drug Review Committee. Dr. Zhang is also responsible for drafting multiple Guideline documents for the CFDA.
Dan received his M.D. from Peking Union Medical College. He obtained his MPH from Harvard School of Public Health. Dan also holds Master's degree in healthcare management from Wharton Business School.
Dr. Emil Fu, SVP International Intergration of FMD
Emil joined FMD in 2013 as Sr. Director, Operations. Prior to joining FMD, he was VP of Research at Ascletis Pharma based in Hangzhou, China. Prior to that, Emil served as VP BioProcess Development at A-Bio, a Singaporian biotech.
Emil has more than 25 years of drug discovery and development experience with Novartis. He served as Vice President and Head of Discovery Technologies at the Novartis Institutes for Biomedical Research in Cambridge, Massachusetts.
Emil obtained his PhD degree in Physical Chemistry from Case Western Reserve University and conducted post dotoral research at Brookhaven National Laboratory in New York.