Safety Reporting Requirements 2 course Suite
Estimated Learning Duration of the Program:
45
Program Description
Program Description:
This suite of 2 courses provides a review of the overall regulatory requirements in EU, US and JAPAN; which documents are applicable and what the different reporting requirements are for both competent authorities and ethics committees. This course will be updated constantly with individual National Competent Authority requirements
Learning Objectives:
The learner will be able to distinguish the different reporting requirements throughout EU, US and Japan for adverse events during clinical investigations
Basics in Regulatory Affairs Certificate
| Course Title Click on a title to view course description | ID | Duration |
|---|---|---|
| European Safety Reporting Requirements during Pre-Market clinical Investigations | 8 | 25 |
| US Safety Reporting Requirements during Pre-Market Clinical Trials | 9 | 20 |
Program Pricing
Prices have not been set for this program.