BIO08041 2014 QUALITY SYSTEMS AND REGULATORY AFFAIRS.
Full Title
QUALITY SYSTEMS AND REGULATORY AFFAIRS.
Transcript Title
QUALITY SYSTEMS.
Code
BIO08041
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2014 - Full Academic Year 2014-15
End Term
9999 - The End of Time
Author(s)
James Murphy, Mary Butler
Programme Membership
SG_SBIOP_K08 201400 Bachelor of Science (Honours) in Science in Biopharmaceutical Science.
SG_SBIOP_E08 201400 Level 8 Certificate in Science in Biopharmaceutical Science
SG_SBIOP_E08 201900 Level 8 Certificate in Science in Biopharmaceutical Science
SG_SBIOP_K08 201900 Bachelor of Science (Honours) in Biopharmaceutical Science.
SG_SBIOP_K08 202200 Bachelor of Science (Honours) in Biopharmaceutical Science (Add-on)
SG_SBIOP_E08 202200 Certificate in Biopharmaceutical Science
Description
This module addresses ICH legislation for biopharmaceutical processing. It also introduces 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.
Demonstrate a broad-based knowledge and understanding of the main US and EU institutions, legal instruments, ICH process and workings of EMEA.
2.
Evaluate applicability of current environmental, health and safety legislation for biopharmaceutical industry.
3.
Source and evaluate procedures and directives currently regulating good manufacturing practices (GMP).
4.
Integrate knowledge and understanding of CTD, variations procedures and Clinical Trial Legislation to evaluate relevant case studies.
5.
Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.
6.
Communicate and explain scientific data relating to quality systems and regulatory affairs.
Teaching and Learning Strategies
as above
Module Assessment Strategies
Continuous Assessment of Course Work - 30% of marks.
End of term online exam - 30% of marks.
Mini research project - 40% of marks.
The miniproject is a MANDATORY form of assessment for any modules on this programme with a miniproject component.
Indicative Syllabus
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
70 %
End of Semester / Year Formal Exam
30 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Open Book Exam Online | Coursework Assessment | UNKNOWN | 15 % | Week 4 | 1,2 |
| 2 | Open Book Exam Online | Coursework Assessment | UNKNOWN | 15 % | Week 9 | 3,4 |
| 3 | Individual Project Mini Research | Coursework Assessment | UNKNOWN | 40 % | Week 15 | 5,6 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Other Exam Online | Final Exam | UNKNOWN | 30 % | Week 13 | 1,2,3,4 |
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Not Specified | Online | 2 | Weekly | 2.00 |
| Directed Learning | Not Specified | Course Notes | 4 | Weekly | 4.00 |
| Independent Learning | UNKNOWN | Mini Research Activities | 4 | Weekly | 4.00 |
Total Part Time Average Weekly Learner Contact Time 6.00 Hours
Module Resources
Non ISBN Literary Resources
Medicines and Healthcare Products Regulatory Agency (MHRA), Rules and Guidance for Pharmaceutical manufacturers & distributors 2007 (Orange Guide). Pharmaceutical Press ISBN:9780853697190.
"Development and Control of Medicines and Medical Devices"; RJ Harman, Pharmaceutical Press.
Pharmaceutics: The Science of Dosage Form Design; M.E Aulton
Other Resources
None
Additional Information
None