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2016-2017 CBA Workshop Series 3

2016-2017 CBA Workshop Series 3

2016-2017 CBA Workshop Series 3

“One Day Experiences”

   A typical work-day of professionals in different functions of the Biopharmaceutical field

Agenda

Clinical Reviewer in FDA

Non-clinical Function in MedImmune

Clinical function in AZ

My Experiences as an FDA Statistician

CBA-USA successfully organized the third seminar of biopharmaceuticaldevelopment workshop on December 18, 2016. This event is co-sponsored by Chinese Culture and Community Service Center (CCACC),Chinese Students and Scholars Association at the National Institute of Health (NIH-CSSA) and American Society for Quality-Washington DC and Maryland Metro, Section 509. Nearly 50 professionals attended the third workshop at CCACC in Gaithersburg, Maryland.

CBA currently has over 3000 registered individual members (www.cba-USA.org).The goal of this series of CBA workshops is to provide opportunities for biomedical professionals to gain a deeper understanding of drug development and marketing approval. At the same time, the CBA workshop is a unique networking platform for local biomedical professionals. Speakers and attendees will have opportunities to discuss the current state-of-art practice, future directions, and career development in biopharmaceutical field.

The second workshop focused on roles of GxPs in ensuring high quality of therapeutic drugs. This time, the third workshop is a special event titled “A typical work-day of professionals in different functions of the Biopharmaceutical field”. We invited seven speakers from pharmaceutical industry and the FDA. They are currently working on drug research, development, CMC, clinical studies and drug review.Many speakers shared their energetic daily work and successful career. Drs. Shen Xiaoand Yeh-Fong Chen from the FDA presented the roles of medical officers and statisticians in drug review process. Followed by Drs. Yuling Wu and Jingya Wang, they shared their daily work and exciting research experience in translational and research at Medimmune. Next, Dr. Jason Bock, vice president of Teva Pharmaceutical Industries (Teva), told an exciting story of how a high school boy curious about scientific became the youngest vice president in Teva. He emphasized the importance of working on the interface of in from AstraZeneca briefly talked about his successful career and how he managed multiple projects in his current director position. Amos Shu described the critical functions of statistical programming in clinical studies. At the end of the workshop, Drs. Frank Li and George Chang hosted the panel discussion and lottery.

CBA is dedicated to bridging the Chinese and US biopharmaceutical industries. We will continue to organize the bimonthly workshop. Next workshop will focus on “Start your own biopharmaceutical business in the US and/or China-Entrepreneurship”. We will post more information early February. Please stay tuned. If you have any advice for this event, please feel free to contact contact@cba-usa.org.

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