Chi-wan Chen serves as Executive Director in Global CMC, Pfizer, responsible for regulatory policies and strategies with a focus on the Asia Pacific region. She chairs the Asia Pacific Focus Group under the International Society of Pharmaceutical Engineering (ISPE), and serves as an ad-hoc CMC advisor to the multinational companies’ trade organization in China and in the South East Asia region. Prior to her joining Pfizer in March 2008, Chi-wan had worked in the U.S. FDA for 22 years. She represented FDA at the ICH on several Quality Guidelines, including Q1AR, Q3AR/Q3BR, and Q8R. In 2005-2008, she provided technical leadership and management oversight for the FDA QbD Pilot Program.