1. 18 December, 2016 In CCACC Gaithersburg, MD, USA
CHINESE BIOPHARMACEUTICAL ASSOCIATION, USA Workshop series-3 “One Day Experiences” A typical work-day of professionals in the Biopharmaceutical field
18 December, 2016
In CCACC Gaithersburg, MD, USA

2. 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

3. 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

4. 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

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