Program Description

Safety Reporting Requirements 2 course Suite

Estimated Learning Duration of the Program:
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

Program Pricing

Prices have not been set for this program.