Drug Development Phase 3 and Regulatory Review
|
Keyword(s)
Drug Development; Clinical Research; Regulatory Affairs; FDA; EMA; Case Study
In the Drug Development Phase 3 and Regulatory Review module learners will review clinical study activities that occur during phase 3, and the regulatory requirements for and components of an application for marketing approval in the US and EU.Register Here!
Credit Information
1.5 ACPE
0.2 IACET
1.5 PMI
0.2 IACET
1.5 PMI
Description
FEATURED TOPICS
- Objectives and Key Players
- Phase 3 Activities
- Safety Reporting Requirements
- Regulatory Review
- The Common Technical Document
- Case Study
- Review