QLTY06006 2016 Introduction to Regulatory Affairs
Full Title
Introduction to Regulatory Affairs
Transcript Title
Intro Reg Aff
Code
QLTY06006
Attendance
N/A %
Subject Area
QLTY - Quality
Department
LIFE - Life Sciences
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2016 - Full Academic Year 2016-17
End Term
9999 - The End of Time
Author(s)
Fiona Donovan, Stephen Daly
Programme Membership
SG_EVALI_S06 201600 Level 6 Special Purpose Award in Validation Technologies
Description
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;
1.
Demonstrate they have a knowledge and understanding of the main regulatory institutions in the EU, USA, and Rest of World and their workings
2.
Demonstrate they have a knowledge and understanding of the ICH and regulatory harmonisations.
3.
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.
4.
Understand the various principles and practices involved in the control and regulation of the medical device industry both in Europe and the USA
5.
Demonstrate a knowledge of the different roles and responsibilities to ensure legal marketing, manufacture, distribution and sale of drugs.
6.
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/Essay | 20 % | Week 11 | 1,2,3,4,5,6 |
| 2 | MCQ1 | Coursework Assessment | Multiple Choice/Short Answer Test | 10 % | Week 5 | 1,2,3 |
| 3 | MCQ 2 | Coursework Assessment | Multiple Choice/Short Answer Test | 10 % | Week 12 | 4,5 |
| 4 | Workshop | Coursework 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