QLTY06006 2016 Introduction to Regulatory Affairs

General Details

Full Title
Introduction to Regulatory Affairs
Transcript Title
Intro Reg Aff
N/A %
Subject Area
QLTY - Quality
LIFE - Life Sciences
06 - NFQ Level 6
05 - 05 Credits
Start Term
2016 - Full Academic Year 2016-17
End Term
9999 - The End of Time
Fiona Donovan, Stephen Daly
Programme Membership
SG_EVALI_S06 201900 Level 6 Special Purpose Award in Engineering in Validation Technologies SG_EVALI_E06 202200 Level 6 Certificate in Validation Technologies with Project

This module aims to provide students with an introductory knowledge and understanding of legislation and Regulatory affairs in EU and US with a particular focus on Biopharmaceuticals and Biologics

Learning Outcomes

On completion of this module the learner will/should be able to;


Demonstrate they have a knowledge and understanding of the main regulatory institutions in the EU, USA, and Rest of World and their workings


Demonstrate they have a knowledge and understanding of the ICH and regulatory harmonisations.


Develop an understanding of the Drug development/Clinical Trial Process with the and how it interacts with the Drug approval process for both Europe and USA.


Understand the various principles and practices involved in the control and regulation of the medical device industry both in Europe and the USA


Demonstrate a  knowledge of the different roles and responsibilities to ensure legal marketing, manufacture, distribution and sale of drugs.


Communicate and explain scientific information in relation to regulatory affairs

Teaching and Learning Strategies

This module can be taught using a combination of synchorous and asynchorous on-line lectures. A range of Computer-Aided Learning (CAL) packages are also used to support this module (e.g. Moodle, Adobe Connect, Panopto, Camtasia) Students are provided with electronic materials for self-assessment and preparation for assessments/assignments. Self-directed, student-centred, independent learning is a core aspect through completion of module coursework. A face to face workshop may also be included as part of the module

Module Assessment Strategies

The assessment approach for this module will be 100% continuous employed including some of the following: Assignments, Short-form assessment exams incl. MCQs, Short answer and Long Answer Questions

Repeat Assessments

Students will need to liaise directly with the lecturer to determine repeat assessment outcomes based on their performance throughout the module.

Indicative Syllabus

The following is a summary of the main topics included in this particular module: EU institutions and EMA; The FDA and the different departments within it; Pharmaceutical legislation from development, registration to pharmacovigilance; Post Approval Changes. Medical device regulations (IVD directive) and role of competent authority and a notified body. CE marking. The IVD directive. 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
60 %
End of Semester / Year Formal Exam
40 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Project Project Written Report 20 % Week 11 1,2,3,4,5,6
2 MCQ1 Continuous Assessment Multiple Choice 10 % Week 5 1,2,3
3 MCQ 2 Continuous Assessment Multiple Choice 10 % Week 12 4,5
4 Workshop Continuous Assessment Group Project 20 % Week 7 6

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam Closed Book Exam 40 % End of Semester 1,2,3,4,5,6

Part Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Distance Learning Suite Online Lecture 1 Weekly 1.00
Group Learning Not Specified Workshop 4 Once Per Semester 0.27
Total Part Time Average Weekly Learner Contact Time 1.27 Hours

Module Resources

Non ISBN Literary Resources


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Additional Information