China Association of Enterprises with Foreign Investment R&D-board Pharmaceutical Association Committee

RA rolling training

Based on the contribution from RA Core Members, the next RA rolling training program is worked out. All RA professionals are invited for participation.

Date:        January 15, 2010, Friday
Time:        08:30 – 18:30
Venue:     Beijing, details TBD

Draft Agenda

1. Regulatory knowledge
 Quality by Design,  by Charles Tong, Pfizer
 GRP in US and EU, by Pan Lihua, Novartis and Li Zili, MSD
 Marketing Authorization System, by Prof Shao Rong, China Pharmaceutical University

2. Clinical knowledge
 Protocol design of global study and local registration study, by Rae Yuan, Roche
 Simultaneous Global Development, by CDE speaker
 Oncology product review, by CDE speaker
 Difference of viewpoint between FDA/EMEA on pivotal study, by Frank Jiang, Sanofi-Aventis

3. Successful regulatory case study, by Wendy Yan, Bayer

Notes:
 The training is open to all RA professional of both Rx and OTC WG
 Registration before Nov 30 please
 Please check this page to get to know the venue and final agenda when the date is approaching
 Working lunch will be prepared, dinner will not be provided for cost control