Agenda China Days "Meet the Dragon" EBF meeting

Day 1 – Thusday 11 September 2014

09:00 – 11:00      Registration

11:00 – 11:05      Welcome

11:05     13:00     Doing business in China

·         Christian Goedel (SinaLingua)
Cultural awareness: things can be confusing, pitfalls, keeping 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 Tan (ICON)
Introduction

·         Dafang Zhong (Shanghai Institute of Materia Medica)
Guideline on bioanalytical method validation in China

·         Daniel Tang (ICON)
CBF activities and involvement in guideline conception and review

·         Discussion

18:00 – 19:00      Reception

Day 2 – Wednesday 12 September

8:30 – 10:30        Clinical studies

·         Peter van Amsterdam (Abbott Established Pharmaceuticals Division)
Introduction to Clinical Trial Applications

·         Pei Hu (Peking Union Medical College Hospital)
Early Phase clinical studies

·         Huafang Li (Shanghai Mental Health Center)
Late Phase Clinical Trials

·         Discussion

10:30 – 11:00      Coffee Break

11:00 – 12:50      Learning by doing

·         Margarete Brudny-Klöppel (Bayer Pharma AG)
How to get the business started

·         Fan Ji (Covance)
Operational and Compliance challenges of setting up Bioanalytical Lab in China

·         Johanna Beekman (Bayer Pharma AG)
Bayer’s experience in sample exportation from China

·         TBD
Central lab perspective

·         Discussion

12:50 – 13:00      Reflections and Close out

13:00 – 14:00      Lunch