Module: Biopharmaceutical Industry Regulation & Quality Management

Module Specifications

Academic Year 2026 - 2027

Module Title	Biopharmaceutical Industry Regulation & Quality Management
Module Code	BTE1052
Faculty	Science & Health	School	Biotechnology
NFQ level	8	Credit Rating	5

Description

1. Distinguish the roles and responsibilities of biopharmaceutical industry professionals within the complex global regulatory environment. 2. Appraise prominent international harmonised and major regional regulatory requirements and guidelines for the manufacturing and marketing of biopharmaceuticals for human use, particularly quality systems of biological medicinal products. 3. Analyse and apply biopharmaceutical quality management practices such as quality risk management (QRM) and deviation investigations using the framework provided by the ICH Guidance on Quality Systems and industry best practice to ensure good manufacturing practice (GMP) and patient safety. 4. Integrate Quality by Design (QbD) principles and risk management tools to propose solutions for complex challenges in the biopharmaceutical development lifecycle. 5. Learn how to defend quality related manufacturing and technical issues and positions to regulatory authorities under audit conditions.

Learning Outcomes

1. Distinguish the roles and responsibilities of biopharmaceutical industry professionals within the complex global regulatory environment.
2. Appraise prominent international harmonised and major regional regulatory requirements and guidelines for the manufacturing and marketing of biopharmaceuticals for human use, particularly quality systems of biological medicinal products.
3. Analyse and apply biopharmaceutical quality management practices such as quality risk management (QRM) and deviation investigations using the framework provided by the ICH Guidance on Quality Systems and industry best practice to ensure good manufacturing practice (GMP) and patient safety
4. Integrate Quality by Design (QbD) principles and risk management tools to propose solutions for complex challenges in the biopharmaceutical development lifecycle
5. Learn how to defend quality related manufacturing and technical issues and positions to regulatory authorities under audit conditions

*Type*	*Hours*	*Description*
Workload	Full time hours per semester
Lecture	18	Attend Class
Independent Study	107	Group work, research and revision.
Total Workload: 125

Section Breakdown
CRN	21497	Part of Term	Semester 2
Coursework	25%	Examination Weight	75%
Grade Scale	40PASS	Pass Both Elements	N
Resit Category	RC3	Best Mark	N
Module Co-ordinator	Caroline Devery Geoghegan	Module Teacher

Type	Description	% of total	Assessment Date
Assessment Breakdown
Assignment	n/a	25%	n/a

Reassessment Requirement Type
Resit arrangements are explained by the following categories; RC1: A resit is available for both^* components of the module. RC2: No resit is available for a 100% coursework module. RC3: No resit is available for the coursework component where there is a coursework and summative examination element. ^* ‘Both’ is used in the context of the module having a coursework/summative examination split; where the module is 100% coursework, there will also be a resit of the assessment

Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml

Indicative Content and Learning Activities

Indicative Reading List

Books:
None

Articles:
None

Other Resources

None