Date |
Time |
Title of Lecture |
04/ 09
|
09:00-10:00
|
The US Site Feasibility |
04/ 09
|
10:00-11:00
|
Conducting Human ADME Studies in the USA: Practical, Scientific, and Regulatory Concerns |
04/ 09
|
11:00-12:00
|
Oncology In vivo Model is the Key for the Pre-clinical Assessment |
04/ 09
|
12:00-13:00
|
점심 시간 |
04/ 09
|
13:00-14:00
|
Non-clinical safety assessment for global IND/NDA |
04/ 09
|
14:00-15:00
|
Clinical Strategy of CAR-T Cell Therapy in Hematological Malignancy |
04/ 09
|
15:00-16:00
|
PV consideration at Drug Level |
04/ 09
|
16:00-17:00
|
Regulatory Concerns about the MRCT Related to China |