Module Code: BS1149

Micro-credential Overview

The Regulatory Compliance Micro-credential presents an overview of the regulations governing the development, manufacture and marketing of drugs and medical devices, inclusive of invitro diagnostic devices.

Aims of the Micro-credential:  

• To provide an overview appreciation of the regulatory framework pertaining to the pharmaceutical and medical device industries.  

• To provide an understanding of how regulatory issues impinge upon the development, manufacture and marketing of these product types.   

• To equip participants with the concepts necessary to enable them to work effectively with regulatory affairs personnel.   

• To act as a reference guide to help participants identify and source specific regulations. 

Start Date

Academic Year 2024/25, Semester 1

Mode of Study

The mode of study for this Micro-credential is Online Learning. 

NFQ Level and ECTs 

Level 8 

5 ECTs 

Application Process

From the 1st April 2024 you can apply for any University of Galway Micro-credential through our 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 & 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

You can find more details on our application process here.

Course Fees


*Fee Subsidy
Candidates who meet the eligibility criteria may qualify for a 50% HEA fee subsidy, subject to the availability of subsidised places. For eligibility details, please refer to the Eligibility Criteria on the Micro-credentials webpage.

This course has also been approved by Galway Executive Skillnet for a fees subsidy of up to 30% for students whose company is a member of their network. For more information, contact: Galway Executive Skillnet – Eamonn Molloy at:

Galway Executive Skillnet Logo 2

NB: Applicants can only apply one subsidy towards their application. 

Entry Requirements

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

Contact Information

If you have any queries please email: