LAW08013 2019 Pharmaceutical Legislation
This module expands on the key areas of the EMA/EU/Irish legislation and US legislation for medicinal products for human use. It also builds on previous knowledge of Eudralex, ICH, PICs, guidance documents 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 US and EU institutions, legal instruments, ICH process and workings of the EMA and FDA.
Source and evaluate the directives and annexes currently regulating pharmaceutical production, placing on the market, pharmaco-vigilance, PQRs, and product falsification within the EU.
Integrate knowledge and understanding of the marketing authorisation process, the variations procedures and Clinical Trial Legislation to evaluate relevant case studies.
Interpret EUDRALEX Volume 2 / ICH M4: ‘Notice to Applicants’ documentation to allow presentation of module contents to peers.
Examine and evaluate Irish legislation pertaining to pharmaceutical products.
Demonstrate a knowledge of current Medical Device regulations/directives and notified bodies.
Teaching and Learning Strategies
This module will be delivered full time. This will include lectures, 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 is 100% Continuous Assessment.
The continuous assessment and course work will involve several assignments/case studies 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.
formative assessment - Self-assessment tests and other forms of formative assessment are provided to students to check their own progress towards achieving the learning outcomes of the module and to motivate learning.
Repeat Continuous Assessment.
1. Demonstrate a detailed knowledge and understanding of the US and EU institutions, legal instruments, ICH process and workings of the EMA and FDA.
Development of Regulatory Affairs, Definitions, Regulatory framework - Directives/Regulations.
Expansion on EU – EMA, US - FDA, European & US legislation and terminology, Licenses required.
2. Source and evaluate the directives and annexes currently regulating pharmaceutical production, placing on the market, pharmaco-vigilance, PQRs, and product falsification within the EU.
European Registration Process. EMA. Responsibilities of MAH, Manufacturer/QP.
Summary of Product Characteristics and Variations and PQR, unique identifier, registration database and internet sales, PSURs.
3. Integrate knowledge and understanding of the marketing authorisation process, the variations procedures and Clinical Trial Legislation to evaluate relevant case studies.
EMA authorisation processes, Clinical Trial Legislation. EUDRACT.
4. Interpret EUDRALEX Volume 2 / ICH M4: ‘Notice to Applicants’ documentation to allow presentation of module contents to peers.
CTD, Quality, Pre-Clinical, Clinical Data and presentation.
5. Examine and evaluate Irish legislation pertaining to pharmaceutical products.
Irish Pharmaceutical Legislation (SI’s).
Principal Regulatory Affairs authorities (Competent Authority) UK/Ireland.
6. Demonstrate a knowledge of current Medical Device regulations and directives and notified bodies.
EU directives/regulations that instruct regulation of medical devices and explain the three main types of medical device under these directives.
Classification of medical devices according to EU and Irish legislation and differentiate between the levels of risk associated with medical device classes.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Multiple Choice||Continuous Assessment||Multiple Choice||40 %||OnGoing||1,2,3,4,5|
|2||Case Study & Presentations||Continuous Assessment||Group Project||30 %||OnGoing||1,2,3,4,5,6|
|3||Assignment & Projects||Continuous Assessment||Assignment||30 %||OnGoing||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
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.
2017-07 Fundamentals of US Regulatory Affairs
ISBN 0997769777 ISBN-13 9780997769777
The Official Journal of the European Union.:https://eur-lex.europa.eu/oj/direct-access.html
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
EMA. From lab to patient: the journey of a centrally authorised medicine.: https://www.ema.europa.eu/en