LAW07026 2019 Legislation, Quality & Auditing Systems
This module introduces EMA/EU/Irish legislation for medicinal products. It also introduces Eudralex Volume 4, ICH, GMP, Auditing, relevant to the Pharma/Biomedical and Medical Device industry.
On completion of this module the learner will/should be able to;
Demonstrate a detailed knowledge and understanding of the main US and EU institutions, legal instruments, ICH process and workings of EMA in relation to medicinal products.
Integrate knowledge and understanding of Common Technical Document (CTD), variations procedures and Clinical Trial Legislation to evaluate relevant case studies.
Source and evaluate guidance procedures and directives currently regulating good manufacturing practices (GMP).
Demonstrate knowledge of the ICH Q9 and Q10 guidance documents as relating to QRM and PQMS for a licensed production facility.
Interpret and understand the relevance of auditing as a means of monitoring the production of safe and efficacious pharmaceutical and medical device products in a GMP environment.
Source, interpret and apply GMP principles to different case scenarios and identify potential issues that would result in implementation of Corrective and Preventative Actions.
Teaching and Learning Strategies
This module will be delivered full time. This will include lectures, and site visits augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a potential means of assessment (e.g. quizzes, uploading assignments and journals).
Module Assessment Strategies
This module will be assessed using a combination of end of semester final exam (60%), continuous assessment and course work (40%).
The continuous assessment and course work will involve Short Answer Questions/Multiple Choice Questions/Assignment Work where students will be required to (i) demonstrate an understanding of core module concepts, and (ii) presentations on topics which demonstrates the student's ability to critically evaluate an aspect of the subject area. there will be a number of MCQs given during the semester
Repeat Continuous Assessment and/or Final Exam.
1 Demonstrate a detailed knowledge and understanding of the main US and EU institutions, legal instruments, ICH process and workings of EMA in relation to medicinal products.
History of Regulatory Affairs, Definitions, Regulatory framework, GMP.
Introduction to European and US legislation & terminology, Licenses required. Principal competent authorities Ireland/EU/USA.
2 Integrate knowledge and understanding of Common Technical Document (CTD), variations procedures and Clinical Trial Legislation to evaluate relevant case studies.
CTD & Clinical Trial Legislation, ICH guidance, Eudralex Vol. 2.
3 Source and evaluate guidance procedures and directives currently regulating good manufacturing practices (GMP).
ICH guidance, Eudralex Vol. 4. + Annexxs
4 Demonstrate knowledge of the ICH Q9 and Q10 guidance documents as relating to QRM and PQMS for a licensed production facility.
Quality Risk Management process and Pharmaceutical Quality Management System.
5. Interpret and understand the relevance of auditing as a means of monitoring the production of safe and efficacious pharmaceutical and medical device products in a GMP environment.
Introduction to GMP and Auditing. (QP role, QMS and role of audits in a GMP environment).
Quality systems. Corrective and Preventive actions (Containment, correction, effectiveness checks), Change Control, Validation, Training, Calibration, Documentation, EHS, Lean Six Sigma/continuous improvement.
5 Source, interpret and apply GMP principles to different case scenarios and identify potential issues that would result in implementation of Corrective and Preventative Actions.
Audit Process- Audit types, techniques, auditor role. Auditing tools, Audit phases, Audit Agendas, Audit preparation, questionnaires and checklists.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Assignment Short Answer Questions/Multiple Choice Questions/Assignment Work||Coursework Assessment||Assessment||20 %||OnGoing||1,2,3,4|
|2||Case Study and presentations||Coursework Assessment||Assignment||20 %||OnGoing||4,5,6|
End of Semester / Year Assessment
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Final Exam||Final Exam||UNKNOWN||60 %||End of Term||1,2,3,4,5,6|
Full Time Mode Workload
|Group Learning||Flat Classroom||Group Learning||1||Weekly||1.00|
|Independent Learning||UNKNOWN||Self Study||4||Weekly||4.00|
Required & Recommended Book List
2017-07 Fundamentals of US Regulatory Affairs
ISBN 0997769777 ISBN-13 9780997769777
2016-08-19 Pharmaceutical Regulatory Affairs Createspace Independent Publishing Platform
ISBN 1537090747 ISBN-13 9781537090740
Regulatory affairs. If you're finishing your academic career and are looking for a job in biotech or pharmaceuticals, you will have seen a thousand advertisements for regulatory affairs managers. But...what exactly is regulatory affairs? What would I be doing? What sort of skills do I need? What do I need to know before I start? This book answers all these questions and more, providing an introduction to the complex world of regulatory affairs. We cover typical tasks; required skills; the ins and outs of the submission process; vital knowledge you'll need to have; and much more. Lost in a sea of acronyms? We've got you covered. Not really sure how regulatory fits into pharmaceutical development? We explain the process. No idea why your new boss keeps going on about module 3.2.P.7? No problem. Whether you're looking for a job, preparing for an interview, or have just started in the field, this book will give you the foundational knowledge you need to succeed.
2017-01-06 Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2017
ISBN 0857112856 ISBN-13 9780857112859
Commonly known as the Orange Guide, this book remains an essential reference for all manufacturers and distributors of medicines in Europe. It provides a single authoritative source of European and UK guidance, information and legislation relating to the manufacture and distribution of human medicines.
EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. Chapters 1- 9. - Self Inspection. : https://ec.europa.eu/health/documents/eudralex/vol-4_en
EudraLex - Volume 1 - Pharmaceutical legislation for medicinal products for human use. : https://ec.europa.eu/health/documents/eudralex/vol-1_en
EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use.: https://ec.europa.eu/health/documents/eudralex/vol-2_en
The European Medicines Agency (EMA), marketing authorisation applications (MAA). : https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation.
EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. Chapters 1- 9. : https://ec.europa.eu/health/documents/eudralex/vol-4_en.
ICH Quality Guidelines.: https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
ICH, CTD/Work Products - M4 : The Common Technical Document.: https://www.ich.org/products/ctd.html