Full Title QUALITY SYSTEMS AND REGULATORY AFFAIRS.

Short Title QUALITY SYSTEMS.

Code BIO08041
Level 08
Credit 05

Author Butler, Mary
Department Life Sciences

Subject Area Bio Tech/Eng/Chem
Attendence N/A%
Fee

Description
This module addresses ICH legislation for biopharmaceutical processing. It also introduces GMP, environmental and health and safety legislation relevant to the biopharmaceutical industry.

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.

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.


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.

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 70 %
End of Semester / Year Formal Examination 30 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Open Book Exam Online 1,2 15 Week 4
Open Book Exam Online 3,4 15 Week 9
Individual Project Mini Research 5,6 40 Week 15


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Other Exam Online 1,2,3,4 30 Week 13


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly 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 Average Weekly Learner Workload 6.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book 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
Url Resources
Additional Info