| Module
1—Development: Setting Up the Environment for Success
|
| Date |
Topic |
Instructor |
| 11
February |
Drug/device
phases |
Lee
Rubin |
| 18
February |
No
class (President's Day) |
|
| 25
February |
Ethical
considerations |
Michele
Welch |
| 3
March |
Legal
implications |
Michelle
Dillione |
| 10
March |
U.S.
regulatory implications |
Gary
Cooper |
| 17
March |
Project/site
management |
Angela
DiSabatino |
| 24
March |
Pre-initiation
visits |
Joann
Di Liberto |
| Module
2—Implementation: Carrying Through the Plan (Globalization
issues incorporated throughout this module.) |
| Date |
Topic |
Instructor |
| 31
March |
Monitoring
visits |
Michele
Welch, Angela DiSabatino |
| 7
April |
Data
management principles |
Junfang
Li |
| 14
April |
Data
management principles, cont. |
Junfang
Li |
| 21
April |
Drug/device
safety |
Wenda
Brennan |
| Module
3 —Integration: Creating the Package |
| Date |
Topic |
Instructor |
| 28
April |
Close
out visits |
Michele
Welch/Angela DiSabatino |
| 5
May |
Auditing |
Kathy
Papp |
| 12
May |
Medical
communications |
Curt
Johnson |
| 19
May |
Marketing
a product |
John
Krukiel |