86-10-65907696RA Rolling Training by Rx Working Group
RA Rolling Training by Rx Working Group
23rd July 2010, Friday
(Vanda Hall, 2F, Beijing Landmark Hotel Venue)
|
Time |
Subjects |
Speakers |
Moderators |
|
08:00 – 08:40 |
Registration |
|
|
|
08:30 – 08:40 |
Opening Speech |
EC advisor (TBC) |
Maggie Chang |
|
08:50 – 09:00 |
Opening Speech |
Li Weiping |
sa |
|
09:00 – 10:00 |
CPP system of US, EU and Japan , Taskforce members |
Theresa Li(Pfizer), Lillian Liang(GSK), Angela Jiang (Novo Nordisk) |
Song Zengli |
|
10:00 – 10:15 |
Coffee Break |
|
|
|
10:15– 11:15 |
Protocol design of global study and integrate into China |
Dr. George Chen (J&J) |
sa |
|
11:15 – 12:15 |
Apply Surrogate End Point to clinical trial |
Kang Cailian (CDE) Xie Songmei (CDE) |
sa |
|
12:15– 13:30 |
Lunch |
|
|
|
13:30 – 14:30 |
Phase I study |
Dr. Hu Pei (PUMC) |
Guo Wenyu |
|
14:30 –17:45 (15:30 – 15:45 Coffee break) |
Drug Development and Regulatory Value of Pharmacokinetic-Pharmacodynamic (PK-PD) Principles and Tools: Principles and Case Studies. |
Bob Powell, Pharm.D. (Roche) |
sa |
|
17:45 – 18:00 |
Closing remarks |
Pan Lihua |
sa |
