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CPhI Conferences 2013
Welcome to Quality by Design China 2013!
Speakers:
 
 
Gu Ziqiang
Gu Ziqiang
Former official of FDA Drug Evaluation and Research Center
FDA
Ning Baoming
Ning Baoming
Research Fellow
National Institute for Food and Drug Control (NIFDC)
Fred Xi
Fred Xi
Ph.D. Vice President, Research & Development
Syrex Laboratories Inc.
Masih Sabet
Masih Sabet
Senior GMP Specialist
NNE Pharmaplan
Chen Binhua
Chen Binhua
General Manager
Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd
Mei Xuefeng
Mei Xuefeng
Director
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Feng Wenhua
Feng Wenhua
Researcher, Institute of Materia Medica (IMM)
Chinese Academy of Medical Sciences & Peking Union Medical College
Hong Ke
Hong Ke
SeniorManager, PAT Projects, Advanced Manufacturing Technology Team
Pfizer Inc.
Zheng Bai
Zheng Bai
Senior Quality Manager
Hansyn Pharmaceutical Co.,Ltd
David Zhao
David Zhao
Senior Vice President
Huahai US, Inc. / Shanghai Prinbury Biopharm. Co., LTD
Luke Wang
Luke Wang
Senior Director of Pharmaceutical Product Development
Huahai US, Inc. / Shanghai Prinbury Biopharm. Co., LTD
Han Jun
Han Jun
General Manager
SOTA Pharmaceutical Inc.
Liang Yi
Liang Yi
Professor
China Pharmaceutical University
Pedro Hermandez
Pedro Hermandez
Senior Director Quality Assurance
Frontage Laboratories Inc.,
Mehtap Saydam
Mehtap Saydam
R&D Specialist
Sanovel Pharmaceuticals
Chen Yisheng
Chen Yisheng
vice president
Novast Laboratories (China) LTD
 
 
 
Background
Due to the proposing of the drug quality documents from FDA and ICH, quality by design has been the consensus of the pharmaceutical industry in China and overseas. But for the Chinese pharmaceutical companies, it’s still a new idea.
With the rapid development of export to US and EU, Chinese companies have the strong demand to deeply understand the QbD regulation in FDA and EMA and it is necessary for them to master the methodology of QbD application to make QbD from ideal to practice.
The requirement of QbD application has been added into the generics registration documents in FDA from January 2013. FDA will no longer accept the application documents without the QbD content, and this is a challenge for Chinese companies.
QbD principles was referred in the new version of GMP in China, it emphasizes the effective relationship between drug registration and drug quality systems. Based on QbD, QbR will be conducted as a new assessment model, which will promote the development of Chinese pharmaceutical industry.
Why Should You Attend?
  • CPhI Brand Assurance: Hottest topics + High quality speech + Best onsite service
  • Hearing in-depth presentations from 15+ global speakers under CPhI resources
  • Following up the latest regulation and QbD practice from FDA and EU
  • Learning the updates of new version of GMP and the conduction of QbR
  • Benefiting from case studies from leading international pharmaceutical companies: including DoE, PAT and other technical methodology form the perspective of QbD for API, generics and excipients
  • Networking with 100+ decision makers from 70+ pharmaceutical companies and 30+ vendor companies
  • More opportunities to communicate with experts and officials from companies and government
Who Should Attend?
Regulatory/Registration
R&D
Analytical
Formulation Development
Product Development
QA
QC
Others
Pharmaceutical Companies
QbD/PAT Consultants
Software Companies
Excipient&API Suppliers
Analytical Instruments
Media Partners