How to develop a Submission Strategy 

This module will provide a broad understanding of the process of developing a submission strategy. It will help you understand the changing regulations, look at some new tools and tackling challenges.

English

100% Online

60 Minutes

APACMed Certificate

Assessments

Interactive

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This module has been developed by:

Marianne Yap 
Vice President,
Quality, Regulatory and Government Affairs,
Asia Pacific, China and Japan
&
John Rossman
Senior Manager,
Regulatory Affairs,
Stryker Corporation

About this Module

Purpose
Learning Objectives
Target Audience
Module Structure
Assessment
Certificate

Why should I enrol in this Module?

This module will provide a broad understanding of the process of developing a submission strategy. It will help you understand the changing regulations, look at some new tools and tackling challenges.

Who should enrol in this Module? 

This Module is suitable for all Pre-Market professionals or anyone with an interest in creating a Submission Strategy.

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.  They are a combination of multiple choice, true and false, and role play scenarios.

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 how:
  • To understand target product profile and changing regulations
  • To learn new development tools for quick market access
  • To learn how to pro-actively recognize challenges & key opportunities
  • To learn to conduct business impact analysis
  • To understand how to make downstream decisions pertaining to testing, labelling and clinical requirements.

When will I get my certificate?

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