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Knowledge Exchange Meeting

China Days - Meet the Dragon

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Maritim Hotel

Berlin, Germany

September 11-12 2014


The program can also be downloaded as a pdf.

Day 1:

09:00 – 11:00     Registration

11:00 – 13:00     Doing business in China

  • Christian Goedel (SinaLingua)
    Cultural awareness: Things can be confusing, pitfalls, loosing face, etiquette
  • Yang Liu (Yang Liu Design)
    East meets West - Yang Liu's personal experience on cultural differences
  • Discussion

13:00 – 14:00     Lunch

14:00 – 15:30     Quality systems and Regulatory Processes

  • Jianan Wang (CFDA)
    Submissions and inspections
  • Andrew Gray (MHRA)
    Is GLP an appropriate standard for laboratories that analyse samples from human clinical trials? - A European perspective
  • Philip Timmerman (Janssen R&D)
    Bioanalysis in China: working in the intersection of global regulations and OECD-GLP
  • Discussion

15:30 – 16:00     Tea Break

16:00 - 18:00      Bioanalytical Guidelines

  • Daniel Tang (ICON)
  • Dafang Zhong (Shangai Institue of Materia Medica)
    Bioanalysis guidelines in China
  • Daniel Tang (ICON)
    CBF activities and involvement in guideline conception and review
  • Discussion

18:00 – 19:00     Reception

Day 2:

8:30 – 10:30       Clinical studies

  • Peter van Amsterdam (Abbot Established Pharmaceuticals Division)
    Introduction to Clinical Trial Applications
  • Pei Hu (Peking Union Medial College Hospital)
    Early Phase clinical studies
  • Huafang Li (Shanghai Mental Health)
    Late Phase clinical studies
  • Discussion

10:30 – 11:00     Coffee Break

11:00 – 13:00     Learning by doing – Sample import / export procedures and experiences

  • Margarete Brudny-Klöppel (Bayer Pharma AG)
    How to get the business started
  • Fan Jin (Covance)
    Operational and compliance challenges of setting up Boanalytical Lab in China
  • Johanna Beekman (Bayer Pharma AG)
    Bayer's experience in sample exporation from China
  • TBD
    Central lab perspective
  • Discussion

13:00                    Reflections and Close out

13:00 – 14:00     Lunch