Post-Market Surveillance & Vigilance:
The Way towards Harmonisation

This module will define post-market surveillance and explain why it is important. It will also provide guidance on adverse vent reporting within the vigilance system and outline vigilance prerequisites and post-market surveillance. It will close with an update on post-market surveillance harmonisation efforts.

English

100% Online

90 minutes

APACMed Certificate

Assessments

Interactive

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This module has been developed by Miang Tanakasemsub

About this Module

Purpose
Learning Objectives
Target Audience
Module Structure
Assessment
Certificate

Why should I enrol in this Module?

This module will define post-market surveillance and explain why it is important. It will also provide guidance on adverse event reporting within the vigilance system and outline vigilance prerequisites and post-market surveillance. It will close with an update on post-market surveillance harmonisation efforts.

Who should enrol in this Module? 

This Module is suitable for all Regulatory Affairs professionals or anyone with an interest in the regulation of medical devices.

How is this Module structured?

This is a self-paced, interactive Module.  It is divided into a number of individual topics so you can easily track your progress and manage your time.

You must watch all of the videos and presentations before the section will be marked as complete.


You can view the structure and individual topics below.

What kind of assessment do I need to do?

This Module contains a number of short knowledge checks and a final assessment.  

You will have unlimited attempts to pass each knowledge check.

What will I learn?

By the end of this module, you will have an understanding of:

  • post-market surveillance and its importance
  • the guidance on adverse event reporting within the vigilance system
  • vigilance prerequisites and post-market surveillance activities 
  • post-market surveillance harmonisation efforts.

When will I get my certificate?

At the completion of the course you will immediately have access to the certificate from APACMed.