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Regulatory Compliance
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
€500*
*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: info@galwayexecutiveskillnet.com
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: sciencetech@universityofgalway.ie
