Change Management

This module will explain change management in terms of approved medical devices and focuses on the need for efficient and effective change management.
Furthermore, it will provide the learner with an overview of the current regulatory landscape of change management and focuses on how agile change management can be an enabler for innovation in the medical technology arena.
Finally, this module shares best practices across different global jurisdictions and insights into the landscape of change management in reference countries that have well-established regulatory mechanisms while also reviewing change management requirements in Asia-Pacific countries.

English

100% Online

120 minutes

APACMed Certificate

Assessments

Interactive

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This module has been co-developed by Dr. Adelheid Schneider

This module has been co-developed by Yasha Huang

About this Module

Purpose
Learning Objectives
Target Audience
Module Structure
Assessment
Certificate

Why should I enrol in this Module?

This module will explain change management in terms of approved medical devices and focuses on the need for efficient and effective change management.
Furthermore, it will provide the learner with an overview of the current regulatory landscape of change management and focuses on how agile change management can be an enabler for innovation in the medical technology arena.
Finally, this module shares best practices across different global jurisdictions and insights into the landscape of change management in reference countries that have well-established regulatory mechanisms while also reviewing change management requirements in Asia-Pacific countries.

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:

  • change management in terms of approved medical devices and the need for efficient and effective change management.
  • the current regulatory landscape of change management
  • how agile change management can be an enabler for Innovation in the medical technology arena
  • best practices across different global jurisdictions,
  • the landscape of change management in reference countries that have well-established regulatory mechanisms and
  • the requirements of change management in Asia-Pacific countries

When will I get my certificate?

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