Biomed/Biotech Special Interest Group  

�Conducting Clinical Trial in China 

� Opportunities and Challenges�

To be presented by

Dan Zhang, MD, MPH, MS

Chairman and CEO

Fountain Medical Development Ltd.

Wednesday (new day in the week), April 8, 2015

6:00 � 6:20 PM � Networking; Pizza/drink 

6:20 � 8:45 PM � Program 

8:45 � 9:00 PM � Door-prizes drawing; Networking

Online Registration site: https://asq509.org/ht/d/DoSurvey/i/35817

Open to Public � 

$5: non-ASQ members to cover pizza/drink cost; 

Free: ASQ members, veterans, senior citizens, past speakers, teachers, students, interns, residents, postdocs, FDA Commissioner�s Fellows, MJ-DC members, NTUAADC members, CAPA members, CKUAADC members, CCACC volunteers/employees, FAPAC members, CBA members, AAGEN members, Commissioned Corp officers, and current job-seekers. 

Location: Kelly�s Deli Conference Center, 7529 Standish Place, Rockville (Derwood, for GPS users), MD 20855

Registration Deadline: Please register by Wednesday noon, April 8, 2015.  

Question: Please contact Dr. C.J. George Chang, Chair of Biomed/Biotech SIG, ASQ509; [email protected] or 240-793-8425 (cell).

Driving directions: By Cars: From I-270 (N or S bound): Take Exit 9A and exit from the FIRST right exit; turn left (east) onto Shady Grove Dr.; turn right (south) onto Rockville Pike (Route 355); turn left (east) onto East Gude Dr.; turn left (north) immediately onto Crabb�s Branch Dr.; turn left (west) immediately onto Standish Place. The first building on your right side is 7519 Standish Place; open parking). The venue is on the first floor of 7529 Building with its external entrance opposite to the left side of 7519 building main entrance. By Metro trains: Off from Red Line Shady Grove Station, and take RideOn Route 59 TOWARD ROCKVILLE and get off from �Calhoun Place� stop. Standish Place is next to the Bus stop. Our venue is within 2 min of walking distance from the stop.

Summary  

China has the largest patient population in the world and thus offers a unique opportunity to conduct global, regional and local clinical trials.  However there are significant differences on GCP regulations and practices between US and China.  Such an asymmetry in regulations produces both opportunities and challenges for running an efficient and yet quality clinical trials in China.  This presentation would compare and contrast GCP regulations and practices between US and China, and try to predict what will happen next.

Speaker�s Bio: 

Dr. Dan Zhang is the Chairman and CEO of Fountain Medical Development Ltd, a full-service clinical CRO with 400 employees operating in South East Asia, China, and USA.  Dr. Zhang is a member of grant application review committee for National Key Drug Development Fund of China, and is also a consultant for the China Food and Drug Administration (CFDA).  He was a member of the Overseas Expert Committee on New Drug R&D for the Ministry of Science and Technology of China.  Dr. Zhang was the Head of Clinical Development at Sigma-Tau Research Inc.  He was a vice president at the Quintiles Transnational Corp. and the Chairman of the Board, Quintiles Medical Development (Shanghai) Company Ltd.

Dr. Zhang received his pre-med training from Peking University and his M.D. from Peking Union Medical College.  He then went to the Harvard School of Public Health and received an MPH in health policy and management.  After then, he went to the Wharton Business School of the University of Pennsylvania, where he obtained his master�s degree in healthcare management in 1998. 

This Biomed/Biotech SIG event is cosponsored by the Monte Jade Science and Technology Association of Greater Washington (www.MonteJadeDC.org) and NTU Alumni Association at DC (www.ntuaadc.org).