Module Details
Module Code: |
PHAR S8015 |
Full Title:
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Regulatory Affairs and GMP Compliance
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Valid From:: |
Semester 1 - 2018/19 ( September 2018 ) |
Language of Instruction: | |
Module Owner:: |
Noelle Cunning
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Module Description: |
The aim of this module is to provide students with an in-depth knowledge of the important role that Good Manufacturing Practice (GMP),Quality systems and regulations plays in the lifecycle of a new drug candidate from discovery to marketing and post marketing.
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Module Learning Outcome |
On successful completion of this module the learner will be able to: |
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Module Learning Outcome Description |
MLO1 |
Discuss and evaluate the pathway for a new drug candidate from premarketing to marketing including discovery, preclinical and clinical trials |
MLO2 |
Interpret the role of Good Manufacturing Practice and quality systems in the discovery, testing, marketing and postmarketing of new drug candidates |
MLO3 |
Examine and discuss international legislation and the role of regulatory authorities in evaluating and approving drug candidates. |
MLO4 |
Describe pharmacovigilance, GVP and risk management plans for new drug products |
Pre-requisite learning |
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named DkIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
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No recommendations listed |
Module Indicative Content |
Pharmaceutical Drug Discovery and development
Introduction to methods used for discovery and development of new drug drug candidates.
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Overview of Pre-clinical studies:
Purpose of pre-clinical studies: Pharmaco-kinetics and pharmaco-dynamics. Safety and toxicity analysis of (novel) compounds. The use of in vitro and in vivo analysis of (novel) compounds. Research Ethics associated
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Overview of Clinical Trials:
Purpose of clinical trials:
Clinical trial design. Introduction to trial size and study population, trial designs and methods of study controls (e.g. randomised, historical and cross-over trial design and blinding). Phase I, II, and III clinical trials and post marketing.
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GMP and Quality systems:
GMP and Quality management, Quality systems to include Complaints, Recalls, Self Inspections and Auditing, pharmacovigilance, GVP and Risk management plans.
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Overview of the role and remit of Regulatory Authorities:
Review of the FDA (USA), EMA (EU) and HPRA(Ire): Structure and mission, role in the pharmaceutical drug development and approval process.
Drug distribution and drug marketing authorisations (incl. IND & NDA applications)
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Marketing
Intellectual property and Advertising
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Module Assessment
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Assessment Breakdown | % |
Course Work | 40.00% |
Final Examination | 60.00% |
Module Special Regulation |
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AssessmentsFull Time On Campus
Reassessment Requirement |
A repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.
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DKIT reserves the right to alter the nature and timings of assessment
Module Workload
Workload: Full Time On Campus |
Workload Type |
Contact Type |
Workload Description |
Frequency |
Average Weekly Learner Workload |
Hours |
Directed Reading |
Non Contact |
n/a |
Every Month |
0.50 |
2 |
Tutorial |
Contact |
n/a |
Every Week |
1.00 |
1 |
Lecture |
Contact |
n/a |
Every Week |
2.00 |
2 |
Independent Study |
Non Contact |
n/a |
Every Week |
5.00 |
5 |
Total Weekly Learner Workload |
8.50 |
Total Weekly Contact Hours |
3.00 |
This module has no Part Time On Campus workload. |
Module Resources
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This module does not have any book resources |
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This module does not have any article/paper resources |
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Other Resources |
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Website, Food & Drug Administration (FDA),
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Website, European Medicines Agency (EMA),
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Website, Health Products Regulatory authority
(HPRA),
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Website, European Directorate for the Quality of
Medicines and Healthcare,
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Website, International Conference on
Harmonisation (ICH),
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Website, British Pharmacopoeia,
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website, 'Eudralex - EU legislation'. Eudralex - EU legislation,
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