18 December, 2016 In CCACC Gaithersburg, MD, USA CHINESE BIOPHARMACEUTICAL ASSOCIATION, USA 2016-2017 Workshop series-3 “One Day Experiences” A typical work-day of professionals in the Biopharmaceutical field 18 December, 2016 In CCACC Gaithersburg, MD, USA

Workshop Organizing Committee CBA: Workshop Organizing Committee CBA: George Chang (FDA), Frank Li (AstraZeneca), Jenny Zhao (Teva), Sun Wei (NIH) CCACC: Chih-Hsiang Li, Edward Wan NIH-CSSA: Bin Zhao, Jun Zhao AQS509: George Chang

Agenda Section 1 12:00-12:30 pm Pizza Lunch and Network Section 2 12:31-1:00 pm Introduction Section 3 1:01-1:45 pm Clinical Reviewer in FDA Shen Xiao, MD, PhD and Yeh-Fong Chen, PhD  Section 4 1:46-2:30 pm CMC Function in TEVA and AZ Jason Bock, Vice President and Chengbin Lin, PhD Break: 5 mins Section 5 2:36-3:15 pm  Non-clinical Function in MedImmune Jingya Wang, PhD, and Yuling Wu, MD, PhD Section 6 3:16-3:40 pm Clinical function in AZ Amos Shu, and Frank Liu, PharmD  Section 7 3:41-4:00 pm Panel discussion

The CTD Triangle NOT Part of the CTD Module 1 Module 2 The CTD Regional Admin Information Module 1 Module 2 Nonclinical Summary Nonclinical Overview The CTD Clinical Summary Clinical Overview Quality Overall Summary Module 4 Nonclinical Study Reports Module 5 Clinical Study Reports Module 3 Quality

Your Opinion on Interesting Topics for future workshops-Feb2017 “Start your own biopharmaceutical business in the US or China-Entrepreneurship”