Drug Development Phase 3 and Regulatory Review

Review phase 3 clinical study activities and the regulatory requirements and components of an application for marketing approval in the US and EU.

概要

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.

Estimated time to complete module: 1.5 hours

This eLearning module can be purchased individually or as part of the Drug Development and Lifecycle Management eLearning Program.

特集トピック

Objectives and key players
Phase 3 activities
Safety reporting requirements
Regulatory review
The Common Technical Document
Case study
Review

参加対象

This module is designed for individuals who are new to, or changing roles in, the pharmaceutical and biotechnology industries. The module will also benefit professionals who work in the areas of:

Clinical Research
Project Management
Administrative Support
Quality Assurance
Regulatory Affairs
Manufacturing
Medical writing
Business Support

学習目的

Upon completion of this module, learners should be able to:

List the clinical study activities of phase 3
Identify safety reporting requirements
Determine the regulatory review process in the US and Europe
Record the components of the CTD

お問い合わせ

Questions?

Send Email