The Biopharma Development & Production (BDP) Week Asia Pacific
November 1-3, 2016
Grant Copthrone Waterfront Hotel, Singapore
Register at: www.biopharmaproduction-asia.com
CBA members could claim 20% off the regular registration rates(08/17/2016)
Bio Partnering APAC 2016 Summit
September 20-21, 2016 | Shanghai, China
-Learn global pharma industry trends to set your own business strategy
-Discover the best collaboration model to improve deal making
-Understand and overcome alliance management challenges with essential and effective practices
-Listen to leading biotechs to find new opportunities
-Meet directly with potential partners to make big deals in your handshake
2016-2017 CBA Workshop Series 2
Role of cGxPs in ensuring high quality of therapeutic drugs
12:00 pm-4:00 pm | Sunday, October 23, 2016
Chinese Culture and Community Service Center (CCACC)
9318 Gaither Road, Suite 226, Gaithersburg, MD 20877
Admission Cost: $5.00 for public
FREE for active members of CBA, CCACC, NIH-CSSA, or ASQ509
CBA-USA is organizing this series of workshops, co-sponsored by CCACC with the goal of providing opportunities for professionals in the bioscience research field to gain a deeper understanding of drug development and marketing approval. Our speakers are experts in this field with hands-on experience in biopharmaceutical industry or Regulatory Authority who will share their expertise with all participants. Come join us on 23 October, 2016 to learn more and meet professionals.
This workshop will address the importance and intent of Good Laboratory Practice (GLP), Current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP) in ensuring high quality of investigational and marketed therapeutic drugs. GxPs provide a framework for well-controlled nonclinical studies, Chemistry Manufacturing and Controls (CMC), and clinical trial conduct and management.
Section 1 12:00-12:30 pm Pizza Lunch and Attendees Self-Introduction
Section 2 12:30-3:30 pm Presentation and Questions/Answers
12:30-1:30 (including Q&A section for 15 min after the presentation)
Introduction of Good Laboratory Practice (GLP): FDA GLP program, including directed and surveillance inspections, will be discussed. The strategy of FDA GLP inspections and some common deficiencies observed in FDA inspections will be shared. The presentation will cover some facts of GLP inspections conducted in China in the past several years.
Speaker: Zhou Chen, MD, PhD, Senior Pharmacologist, Office of Study Integrity and Surveillance (OSIS), CDER, FDA
1:30-2:30 (including Q&A section for 15 min after the presentation)
Current Good Manufacturing Practice (cGMP) in drug development
Speaker: Gang Wang, PhD, Senior Interdisciplinary Scientist, OMQ, Office of Compliance, CDER, FDA
2:30-3:30 (including Q&A section for 15 min after the presentation)
Good Clinical Practice (GCP) in drug development
Speaker: Dan Zhang, MD, MPH, MBA, CEO, Global Medicine Development
Section 3 3:30-4:00 Panel Discussion and Closing Remark
Biosketches of Speakers
Zhou Chen, MD, PhD, Senior Pharmacologist, OSIS, Office of Translational Sciences, CDER, FDA
Dr. Zhou Chen joined FDA/CDER in 1998 as a Pharmacology/Toxicology reviewer covering pre-clinical safety evaluations for IND and NDA. In 2009, he joined the Office of Compliance performing inspections for the Bioequivalence and GLP Branch. Dr. Chen is now a Team Leader for the Division of New Drug Bioequivalence, Office of Study Integrity and Surveillance responsible for the selection of nonclinical sites for surveillance, evaluating the conduct of inspections for GLP and non-GLP studies.
Gang Wang, PhD, Senior Interdisciplinary Scientist, OMQ, Office of Compliance, CDER, FDA
Dr. Wang is a Senior interdisciplinary scientist in Office of Compliance. Most recently, he returned from a 4-year detail as the Deputy Assistant Country Director for FDA’s China Office, analyzed regulatory policies and administered regulatory trainings in China. Dr. Wang received his B.S. from Nanjing University and Ph.D. from Dartmouth Medical School. He was an Assistant Professor and Principal Investigator at the University of Texas M.D. Anderson Cancer Center prior to joining FDA in 2005.
Dan Zhang, MD, MPH, MBA, CEO, Fountain Medicine Development Ltd.
Dr. Dan Zhang is the Chairman and CEO of Fountain Medical Development (FMD), a full-service CRO with 400 employees operating in Southeastern Asia, China, and USA. Dr. Zhang held several senior positions in Sigma-Tau, Quintiles before establishing FMD. Dr. Zhang received his medical training from Peking Union Medical College (including pre-med in Peking University), MPH from Harvard University, and MBA from University of Pennsylvania. Dr. Zhang was 2006-07 CBA president and is a Board member of CBA.
CBA workshop organizing committee c/o Frank Li
Chinese Biopharmaceutical Association (CBA-USA)
PO Box 61362, Potomac, MD 20859-1362
Career Workshop Presentations：