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.

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 April 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:

Academic level: Micro-credentials and CPD
College/Interest type: Micro-credentials/CPD Undergrad Level 7 and 8
Academic programme: Science and Technology Micro-credentials CPB1

You will need to manually enter the Module Name and Code under ‘Module Name’ on the second page of your application. Please copy the name and code below:

Regulatory Compliance - BS1149