Regulatory Intelligence

This module will define the concept of regulatory intelligence and describe its key components and information flow.
This module will also lay out the value proposition of regulatory intelligence, explain the concepts of monitoring versus researching and list the factors influencing intelligence sharing and cadence while highlighting the types and sources of information processed as regulatory intelligence.
Finally, the module will present regulatory intelligence challenges and best practices.

English

100% Online

60 minutes

APACMed Certificate

Assessments

Interactive

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This module has been developed by
Winson Teng

About this Module

Purpose
Learning Objectives
Target Audience
Module Structure
Assessment
Certificate

Why should I enrol in this Module?

This module will define the concept of regulatory intelligence and describe its key components and information flow. This module will also lay out the value proposition of regulatory intelligence, explain the concepts of monitoring versus researching and list the factors influencing intelligence sharing and cadence while highlighting the types and sources of information processed as regulatory intelligence. Finally, the module will present regulatory intelligence challenges and best practices.

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:

  • A definition of Regulatory Intelligence (RI)
  • RI key components, information flow and value proposition
  • the concept of monitoring versus researching
  • the factors influencing RI sharing and cadence
  • the type and source of information
  • RI challenges and best practices

When will I get my certificate?

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