REGU09022 2022 Regulation, Risk and Compliance

General Details

Full Title
Regulation, Risk and Compliance
Transcript Title
Regulation, Risk and Complianc
N/A %
Subject Area
REGU - Regulatory Affairs
LIFE - Life Sciences
09 - NFQ Level 9
05 - 05 Credits
Start Term
2022 - Full Academic Year 2022-23
End Term
9999 - The End of Time
Mary Butler, Stephen Daly
Programme Membership
SG_SBIOI_E09 202100 Postgraduate Certificate in BioIndustry 4.0 SG_SVALI_O09 202300 Postgraduate Diploma in Science in Validation and Digitalisation Technologies SG_SVALI_O09 202300 Postgraduate Diploma in Science in Validation and Digitalisation Technologies SG_SVALI_M09 202300 Master of Science in Validation and Digitalisation Technologies SG_SVALD_O09 202300 Postgraduate Diploma in Science in BioPharmaceutical Validation and Digitalisation

This module aims to provide students with an understanding of the main regulations and regulatory bodies associated with biopharmaceutical manufacturing, with a focus on Bio-Industry 4.0. It also provides students with the application of the validation concepts and how risk management is an integral part of this.

Learning Outcomes

On completion of this module the learner will/should be able to;


Demonstrate an understanding of the global regulatory framework for biotechnology derived products


Discuss how the nature and production of biotechnology products affects quality, safety and efficacy and Engage in and demonstrate independent learning as well as communicate effectively as an Individual and or a member of a team


Differentiate the applications of EU & US regulations for biopharmaceutical marketing authorisations


Categorise the principal risks associated with the manufacture of modern biopharmaceuticals and tools to evaluate them including the latest digital trends and technologies


Critically evaluate the main steps involved in the validation of upstream (cell culture processing) and downstream (protein purification) processes as well as cleaning, sterilisation, and viral control technologies in the manufacture of biopharmaceuticals including trends in digitalisation.

Teaching and Learning Strategies

This module will be taught using on‑line lectures. A range of Computer‑Aided Learning (CAL) packages are also used to support this module (e.g. Moodle,Adobe Connect, Panopto, Camtasia). Students are provided with electronic materials for self‑assessment and preparation for assessments/assignments. Self‑directed, student‑centred, independent learning is a core aspect through completion of module coursework.

Module Assessment Strategies

The assessment approach for this module will be 100% continuous employed including some of the following: Enquiry based Projects, Assignments/mini projects including Viva/Presentation Short-form assessment exams incl. MCQs, Short answer and Long Answer Questions.

Repeat Assessments

Students will have opportunities to re-submit work  as agreed with their lecturer.

Indicative Syllabus


The following is a summary of the main topics included in this module: Overview of the EMA, FDA, and ICH, Introduction to Clinical Trials and Drug Development (CTA, IMPD, IND) and Bio Industry 4.0, TSE risks Advanced Therapies Biosimilars QBD, FDA & EU GMP regulations for pharma/biopharma manufacture, Validation Master Plan, validation life cycle, Upstream and Downstream, Cleaning and Viral Clearance, digitalisation, Risk Identification, Risk Assessment and Risk Management for Biopharmaceutical Manufacture in light of industry 4.0 developments (ICH Q9).


Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 MCQ 1 Coursework Assessment Multiple Choice/Short Answer Test 10 % Week 5 1,2
2 MCQ 2 Coursework Assessment Multiple Choice/Short Answer Test 10 % Week 9 3,4
3 End of Semester Assessment Coursework Assessment Assignment 20 % Week 12 1,2,3,4,5
4 Project & Viva Project Closed Book Exam 40 % Week 12 1,2,3,4,5
5 Gp Project Project Group Project 20 % Week 11 2,3,4,5

Part Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Online Lecture 2 Weekly 2.00
Independent Learning Not Specified Self Study 5 Weekly 5.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Required Reading
2013-04-25 Pharmaceutical Biotechnology John Wiley & Sons
ISBN 9781118685754 ISBN-13 111868575X

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific product category chapters focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

Required Reading
2007-09-25 Validation of Pharmaceutical Processes, Third Edition CRC Press
ISBN 0849370558 ISBN-13 9780849370557

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process. Presenting theoretical knowledge and applied practical considerations, this title provides an in-depth discussion of recent advances in sterilization identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions

Module Resources

Non ISBN Literary Resources
Journal Resources

Pharmaceutical Drug Regulatory Affairs Journal

URL Resources

Other Resources

ICH. (2008)


ICH (2009)


FDA. (2004)


EMA. (2003) EMA PAT Team

Additional Information