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Biomed/Biotech Special Interest Group Meeting  

Kelly's Deli Conference Center
Next to the entrance to 7519 Standish Drive
FDA/CVM Center
Rockville, Maryland  20855

May 23    6:00 pm - 8:45 pm (GMT -5:00) EST

**Online Registration: Due to space limitations, we are forced to CLOSE the event registration for new attendees.  The Biomed/Biotech SIG regrets this action.**

**We will consider to hold a similar event in the future.**


“Career Opportunities at FDA 
– From A Regulatory Scientist Perspective”

To be presented by

Ke Zhang, PhD
Senior Pharmacologist
Division of Gastrointestinal and Inborn Errors Products
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)

Thursday, May 23, 2013

6:00 – 6:20 PM – Networking; Pizza/drink 
6:20 – 8:00 PM – Program 
8:00 – 8:30 PM – Door-prizes drawing; Networking

Online * Registration is closed earlier due to overwhelming responses*
Open to Public – 
$5: non-ASQ members to cover pizza/drink cost; 
Free: ASQ members, MJ-DC members, CAPA-DC members, CCACC employees and volunteers, veterans, senior citizens, students, interns, residents, postdocs, FDA Commissioner’s Fellows, and current job-seekers 
Location: Kelly’s Deli Conference Center, 7519 Standish Place, Rockville (Derwood, for GPS user), MD 20855
Registration Deadline: Please register by Thursday noon, May 23, 2013.  
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 with its entrance opposite to the left side of 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.

The speaker will discuss his daily routines as a regulatory scientist at FDA, the basic requirements to become one, and other scientific disciplines at FDA.  He will also share with the audience his unique experience, lessons learned in the past, and challenges as a regulatory scientist for the past two decades while working at FDA – a dynamic organization.    

Presenters’ Bio:
Dr. Ke Zhang was trained as a cardiovascular pharmacologist, received his Ph.D. from the Ohio State University in Columbus, Ohio, and did his postdoctoral training at Northwestern University in Chicago, IL.  He joined FDA in 1994, when PDUFA I (the first authorization of Prescription Drug User Fee Act) was in its early implementation, as a pharmacologist reviewer in the Division of Gastrointestinal and Inborn Errors Products in the Office of New Drugs, Center of Drug Evaluation and Research (CDER).  He is currently a senior pharmacologist reviewer. 

SIG Chair’s Note: On July 9, 2012, the fifth authorization of PDUFA was signed into law through the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.  Each PDUFA authorization period has been 5 years.  http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm272170.htm

This Biomed/Biotech SIG event is cosponsored by the Monte Jade Science and Technology Association of Greater Washington (www.MonteJadeDC.org) and the Chinese American Professionals Association (www.capadc.org).