BIO08049 2020 Quality Systems and Regulatory Affairs
Full Title
Quality Systems and Regulatory Affairs
Transcript Title
Quality Systems & Regulatory A
Code
BIO08049
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
08 - Level 8
Credit
10 - 10 Credits
Duration
Semester
Fee
€
Start Term
2020 - Full Academic Year 2020-21
End Term
9999 - The End of Time
Author(s)
Stephen Daly, Kevin Colonna
Programme Membership
SG_SBIOM_H08 202000 Bachelor of Science (Honours) in Biomedical and Bioindustrial Sciences
SG_SAPMS_H08 202000 Bachelor of Science (Honours) in Applied Medical Sciences
Description
This module addresses advanced aspects of quality systems and regulatory affairs including legislation for biopharmaceutical processing sufficient for further study and professional practice in the biomedical sciences.
This module is designed to provide an in-depth understanding of quality systems and regulatory affairs including legislation for biopharmaceutical processing.
Aim:
To provide an in-depth knowledge and understanding of the International Council for Harmonisation (ICH) legislation for biopharmaceutical processing, GMP, environmental, and health and safety legislation, relevant to the biopharmaceutical industry.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Explain in detail the main US and EU institutions, legal instruments, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) process and workings of the European Medicines Agency (EMEA).
2.
Integrate concepts of the common technical document (CTD), variations procedures and Clinical Trial Legislation to evaluate relevant case studies.
3.
Evaluate applicability of current environmental, and health and safety legislation for the biopharmaceutical industry, and procedures and directives currently regulating good manufacturing practices (GMP).
4.
Perform research relating to quality systems, and then analyse, evaluate, draw reasoned conclusions and generate a report.
Teaching and Learning Strategies
This module is taught by lectures supported by self-directed reading material, and project assignments. A range of Computer-Aided Learning (CAL) packages are also used to support this module. Students are provided with electronic materials for self-assessment and preparation for examinations. Self-directed, student-centred, independent learning is also encouraged through completion of module coursework.
Module Assessment Strategies
Class Test [60%]
Three open-book Class Tests will be conducted during the module testing core aspects of module content. Feedback will be provided via moodle platform.
Project [40%]
A research type project will be undertaken over the course of the module and the outcomes will be assessed as a written report (2000 words) incorporating problem solving. Written feedback will be provided on a bespoke feedback sheet, giving the breakdown of marks and comments.
100% Coursework 0% Examination
Repeat Assessments
Set by the lecturer depending on the failed element.
Indicative Syllabus
This module will blend lecture material with applied content that includes the following: History of Regulatory Affairs, Definitions, Regulatory framework, GMP.US FDA, Introduction to European legislation & terminology, Licenses required. European Registration Process. EMEA. Responsibilities of MAH, Manufacturer/QP. Principal Reg Affairs authorities UK/Ireland.Irish Pharmaceutical Legislation.Summary of Product Characteristics and Variations.Environmental Legislation.Health and Safety Legislation.CTD & Clinical Trial Legislation.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Class Test | Coursework Assessment | Open Book Exam | 60 % | OnGoing | 1,2,3,4 |
| 2 | Project | Project | Written Report/Essay | 40 % | OnGoing | 1,2,3,4 |
Online Learning Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Online | Online lectures | 2 | Weekly | 2.00 |
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours
Module Resources
Non ISBN Literary Resources
Required:
Aulton, M. E. and Taylor, K.M.G. (2017) Aulton's Pharmaceutics: The design and manufacture of medicines (5th edition). London, Churchill Livingstone
Harman, R.J. (2005) Development and control of medicines and medical devices. London, Pharmaceutical Press.
Medicines and Healthcare Products Regulatory Agency (MHRA) (2017) Rules and Guidance for Pharmaceutical manufacturers and distributors (The Orange Guide) (10th edition).
London, Pharmaceutical Press.
Recommended:
Students will also be directed to online resources as required, including relevant up-to-date scientific literature, and to other relevant reading material during teaching sessions and via the online module materials.
URL Resources
N/A
Other Resources
N/A
Additional Information
N/A