Overview

This module presents an overview of the regulations governing the development, manufacture and marketing of drugs and medical devices, inclusive of in vitro diagnostic devices.

Entry Requirements

Applicants should be over 21 years and have a Level 7 qualification. Applicants may be considered using Recognition of Prior Learning.

What you will Learn

• General principles of regulation in terms of their purpose, legal basis, structure and scope, as well as the key regulatory bodies that are involved in their development and enforcement.
• Processes: The process for bringing a new human drug to market, starting with drug discovery and ending in obtaining marketing approval.
• Controls and monitoring: How manufacturing and performance on the market are controlled and monitored.

Course Outcomes
On successful completion of this micro-credential, you will receive credits as per the European Credit and Transfer System. These credits are recognised by the awarding institution as credits aligned to learning completed at undergraduate level 8.

Learning Outcomes

1. Examine the regulatory framework pertaining to the pharmaceutical and medical device industries
2. Recognise how regulatory issues impinge upon the development, manufacture and marketing of pharmaceutical and medical device products
3. Apply concepts that enable individuals to work effectively with regulatory affairs personnel
4. Describe the assembly of a technical dossier supporting a marketing authorisation application
5. Identify and source specific regulations

Assessments

• Continuous Assessment (100%)

Contact

If you have any questions about this course, please contact:

Science & Technology Studies,
Centre for Adult Learning & Professional Development

Email: Science & Technology

How to Apply

From the 1st May 2025, you can apply for this micro-credential through our Online Application Portal.

Learn more about our application process.

Apply here: Online Application Portal

When completing your application please make sure to select the following categories:

College/Interest Type: Science & Technology

Academic Programme: Select your micro-credential from the drop-down list 

Academic Term: Select the academic term Autumn 2025 (Semester 1) or Spring 2026 (Semester2) 

On Page 2 of the application for please select the following Course Instance: Science & Technology micro-credentials CPB1