SHANGHAI, April 17, 2014 /PRNewswire/ -- In 2014 CPhI Global Pharma Congress, experts from drug manufacturers and research institution will discuss the transportation of Chinese pharmacy and formulation innovation & techniques.
Part of our distinguished speaker
Mel Dong, Former FDA Officer, Head of Blue-Bell Consulting
Topic: Action and prospects from regulator: Updates of Three-years Test Plan of QbD from FDA and EMA
Personal Bio: Dr. Dong was a U.S. FDAer responsible for premarket clearance of submissions by regulated industries as well as a member of FDA inspection team and participated in numerous on-site inspections. With over 25 years of experience in the U.S., Dr. Dong founded Blue Bell Consulting in Shanghai, China in 2003. Dr. Dong frequently audits pharmaceutical companies, suppliers, and contract manufacturers in the region. He also helps API and dosage form pharmaceutical companies in handling of FDA inspections, citations, and regulatory actions. Dr. Dong provides consultation services to the China Food and Drug Administration (CFDA) and provincial CFDA in China on compliance and regulatory issues.
Jing Qiang, VP of Research Department, CICC
Topic: Internalization of Chinese pharmacy, the global industry trend and development opportunities
Personal Bio: Mr. Qiang Jing currently works in CICC as a VP in the research department. Mr. Qiang joined CICC in 2010 and is now head of healthcare research team covering A-shares and overseas-listed pharmaceutical companies. Prior to the career in CICC, Mr. Qiang was a derivative risk management analyst in Citibank. He is also a contributing researcher in China Society of Economic Reform (CSER). Mr. Qiang graduated from Fudan University in 2010 as a Master in Finance and he is holding CFA and FRM designations.
Lianli Li, VP of R&D, PharmaMax
Topic: Establish statistics method and DoE to make QbD practice more effective
Personal Bio: Dr. Li has over 14 years U.S. pharmaceutical industry experience in the area of Formulation and Process Development. She worked for Bristol-Myers-Squibb, Barr Pharmaceuticals, KV Pharmaceuticals, Covidien, and DanSol Pharma. She is the inventor of over 10 U.S. and international patents. She developed over 15 products that were approved by U.S. FDA. Her specialty includes sustained/controlled release solid dosage forms, pellet coating, nanoparticles, microemulsions, orally disintegrating tablets, trans-musocal drug delivery systems, peptide delivery, Design of Experiments (DOE), and Quality by Design (QbD). She completed Six Sigma Black Belt Training. She also possesses strong analytical, pharmacokinetics, regulatory, clinical, and legal knowledge in pharmaceutical development.
More Confirmed Speakers:
Jiuhong Wu, Director of Pharmaceutical Department, The 306th Hospital of PLA
Jason Liou, Senior Quality & Regulatory Consult, Hansyn Pharmaceutical
Haibin Qu, Professor & Head, Pharmaceutical Informatics Institute, Zhejiang University
Luke Wang, Senior Product Development Director, Huahai US
Fred Xi, Vice President, USP China
Weizhan Liu, Secretary General, China Pharmacy Cold Chain Alliance (CPCCA)
Stephen Maietta,Head of Global Key Accounts, Envirotainer
Michael Lee, Vice President, TDW Pharmaceutical
Steven Liu, VP Supply Chain, Novo Nordisk (China)
Marco Antonio Vega, Head of China Quality, Eli Lilly and Company (Shanghai)
Xuefeng Mei, Director, Shanghai Institute of Materia Medica
Weijie Fang, Director of Biopharmaceutical Analysis and Formulation, Hisun Pharmaceuticals
Global Pharma Congress 2014
Focus on Transformation of Chinese Pharmacy and Formulations Innovation & Techniques
SOURCE UBM China