Introduction

This course is designed to help with the development of pharmaceutical or healthcare technology products.

The course is designed to help you: 

• Start a discussion with a relevant partner and/or to take forward an idea into a phase of development that is regulated.
• Identify appropriate future markets for your idea and how to navigate the regulatory practices that may be applicable.
• Evaluate risks and prepare safe conditions for the investigation of your idea.

This course is an Open Online Course (OOC) and was created and has been adopted from Peoples-uni. It was further developed by NextGenU.org (NGU).

There are four (4) modules to complete, which include:

Module 1: Is Your Idea Marketable?
Module 2: How do You Choose Partners to Develop the Product?
Module 3: How do You Get your Product Fit for Marketing?
Module 4: What Happens After Marketing Approval?

Approximate time for completion of this course is 5 hours at an average reading rate of 144 words/minute.

Engaging with this course

• To register for this course, complete the registration form. Begin the course with Module 1. For each lesson, read the description. 
• Each lesson comprises introductory remarks. You can click on the collections of resources in each module. 
• There is a forum on each module for reflection, and you will be able to add a new topic or respond to a previous one. You may want to share your learning from this and other readings, comment on the topics from your own experience, comment on others' posts, or provide feedback on how we can improve the content and/or presentation.
• There is a final quiz to assess your understanding of some important concepts. Click on the hyperlinks to take you to these items in each topic.

Requirements to obtain the certificate 

You may browse this course for free to learn for your personal enrichment. There are no requirements.

To PASS and Obtain a Certificate

• All reading requirements
• All discussion forums
• The final exam with a minimum of 80% and a maximum of 3 attempts and
• The self and course evaluation forms

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Learning Outcomes:

By the end of this Module, you will be able to:

• Know how to get started
• Decide if it is my/our idea to develop
• Understand if my/our idea is going to matter/succeed against a large pharmaceutical or technology company
• Appreciate the environmental and other conditions affecting my idea
• Decide how to protect your idea

Learning Outcomes:

By the end of this Module, you will  :

• Decide if you need a partner or partnerships
• Understand the consequences of making an advertising claim for your idea which has not been proven with evidence
• Understand how your idea is developed in regulatory phases and common procedures for obtaining regulatory approval
• Understand the challenges facing supply chains for manufacture before and after regulatory approval

Learning Outcomes:

By the end of this Module, you will be able to:

• Understand how safety reporting and vigilance work before and after regulatory approval.
• Identify and document risks to the safety, efficacy and feasibility of your product.
• Understand the concept of liability.

Learning Outcomes:

By the end of this Module, you will be able to:

• Review a possible business model that you planned for your product and consider options whether you want to expand to other markets or other products - based on your original motivation.
• Appreciate that health policies vary across countries and continents including which essential medicinal products are going to be reimbursed at a national level, which will affect your initial business plan.

Click here to start Final Examination

This section includes a Quiz for you to test your knowledge of the issues raised during the course. We also ask that you evaluate the course as your feedback will help us to improve it. You can also earn a certificate if you complete the quiz.