Focus Workshop Slides 2014 September
Program of EBF Workshop “China Days – Meet the Dragon” September 11-12, 2014
PDF renditions of the powerpoint presentations can be viewed and downloaded from this page by clicking the specific point on the program.The program itself can be viewed and downloaded by clicking here
Day 1: September 11 – 2014
11:00 – 13:00 Doing business in China
- Introduction and Agenda
- 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
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
16:00 – 18:00 Bioanalytical Guidelines
- Daniel Tang (ICON)
Introduction - Dafang Zhong (Shangai Institue of Materia Medica)
Bioanalysis guidelines in China
Day 2: September 12 – 2014
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
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
13:00 Reflections and Close out
