Program Description

Pre-Market Safety Reporting Certificate

Estimated Learning Duration of the Program:
1-2 days
Program Description:

This program examines global safety reporting requirements during pre-market clinical investigations and outlines the event and reporting processes, trend analyses, and corrective and preventive actions.

The content of this program is based on:

  • EU MEDDEV 2.7/3 and applicable sections of EU medical device directives
  • USA FDA 21 CFR 812.150

Further review of the setup and management of safety committees can be found in the Clinical Events Committee and Safety Monitoring Board, which plays an important role in the review of safety data during clinical trials.

Learning Objectives:

Upon successfully completing this program, learners will be able to:

  • Develop, manage, and control an efficient safety reporting system in compliance with the EU, US, and other national regulatory systems throughout the world

Price:€ 367.00

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