中文
Sponsor
Exhibitors
Media Partner
Event Introduction
The Chinese Pharmaceutical market is being challenged by increasing pressure to create and maintain the proper quality systems to enhance quality and reduce costs. ISPE and FDA with participation by Chinese National Companies have created a unique conference dedicated to successful implementation of ICH Q10.

Learning Objectives:
  • • Learn the principles of ICH Q10 through establishing Pharmaceutical Quality Systems (PQS);
  • • Learn the practicalities of how to implement an ICH Q10 based PQS based on real-life case studies;
  • • Understand the benefits of establishing and maintaining a state of control to enhance regulatory compliance

Who Should Attend

The decision-makers at mid-level or senior level, or a professional working at site or corporate level in Quality Assurance, Quality Risk Management, Supply Chain, Pharmaceutical Development and CMC, Regulatory Affairs, Six-sigma and Quality by Design, Manufacturing, Operations and Engineering.

Speaker
  • Richard L. FriedmanDirector of the Division of Manufacturing & Product QualityCDER
  • Joseph FamulareVice President Global Quality Compliance and External CollaborationGenentech/Roche
  • Joanne BarrickAdvisor,Global Process Validation,Technical/Manufacturing ScienceEli Lilly
  • George FranceNovartis
  • Nigel HamiltonHead of Quality Intelligence and Strategic Projects, Sanofi, Paris, France
  • Marty LipaExecutive DirectorMerck Manufacturing Division Knowledge Management and Learning Technologies COE
  • George P. MilliliSenior Principal Technical Advisor, Compliance and External Collaboration, Genentech
  • Chuanyong Shen, Deputy Director of Center for Certification of DrugCFDA
  • Cindy ShenSenior principle technology advisor of Shanghai Roche Pharmaceutical Ltd.
  • Janeen SkutnikVice PresidentNSF Health Sciences Pharma Biotec
  • Charles TongGeneral Manager of R&D Centre, Hisun-Pfizer Pharmaceuticals Company
  • Fionnuala M. WalshSenior vice president of quality for Lilly
  • Weibing WangVice president of quality of Zhejiang Hisun pharmaceutical Co.
  • Glenn WrightDirector, Project Management, Technical Services/Manufacturing Science, Eli Lilly
  • Jerry XuVice President of GMP QA and Regulatory Affairsof Wuxi Apptec
  • Peter ShearstoneLead Director, Regulatory Communication and Program Management Global Quality Team
  • Tiewei ZhaiCenter for Certification of Drug of SFDA
  • Kris EvansExecutive director of Quality Sciences at Amgen
  • Stephen TylerDirector of Quality Engineering in Operations Quality Systems at AbbVie
  • G.K. RajuG.K. RajuChairman and CEO of Light Pharma Incorporated
  • Zhen YangSenior project manager Marketing and Law Department of Truking Technology
Contact US
Registration Hotline: +86-21-2312-3640
Sponsor and Exhibition: +86-21-2312-3518 Email: chinaevent@ispe.org Mciro-blog: www.weibo.com/ispechina We-chat:
Conference Brochure Download
ISPE China Annual Conference 2013-ISPE
Hotline: 86-21-2312-3640 Fax: 86-21-2312-3699 E-mail:chinaevent@ispe.org