REGU09012 2019 Post Market Surveillance
Full Title
Post Market Surveillance
Transcript Title
Post Market Surveillance
Code
REGU09012
Attendance
N/A %
Subject Area
REGU - Regulatory Affairs
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SMEDI_O09 201900 Postgraduate Diploma in Science in Medical Device Regulatory Affairs
SG_SMEDI_M09 201900 Master of Science in Medical Technology Regulatory Affairs
SG_SMEDI_C09 202100 Postgraduate Certificate in Medical Device Regulatory Affairs
Description
This module is taken by Level 9 students in Medical Technology Regulatory Affairs and it aims to provide students with a detailed knowledge and understanding of post market requirements for medical devices. Specifically this module aims to develop the students ability to create and implement a comprehensive post market surveillance plan to collect, evaluate and respond to data on device safety and performance after market approval.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Demonstrate detailed knowledge and understanding of global PMS requirements with particular emphasis on US and EU.
2.
Illustrate detailed knowledge and understanding of post market surveillance requirements and development of a post market surveillance plan that is consistent with the risk associated with the device based on its intended use
3.
Understand complaint management and assessment, evaluation and responses to post market data that is risk appropriate
4.
Formulate and communicate a post marketing surveillance strategy which meets regulatory requirements
5.
Illustrate an understanding of all types of potential field actions including FSCA, CA's, Advisory notices, recalls including recall letters and types of recalls
6.
Understand PMS data analysis including MAUDE and EUDAMED and complaint trend analysis
Teaching and Learning Strategies
The educational elements will be provided by the Institute of Technology Sligo, NUI Galway and NIBRT staff. Additional lecturing, as required, may be provided by outside specialists and practitioners. Online/blended programmes are designed for students who want to study part-time at a pace that matches their work-life balance. Through a combination of blended delivery formats including online (synchronous and asynchronous) as well as other technologies we strive to reach the forefront of emerging breakthroughs in the delivery and assessment of online students.
Module Assessment Strategies
The module will be assessed on the basis of 100% continuous assessment. Some or all of the following assessment modes may apply: examinations, practical work, projects, essays, vivas, seminars, and assignments. These assessments may be organised at different centres throughout the country and a selection of assignments may be assessed.
Sample Technologies in use during assessments
• Moodle
• Adobe connect
• Turnitin
• Panopto
• Microsoft office
• Multimedia including DVDs, webinars, youtube video clips, online videos
Repeat Assessments
The programme allows students to progress to a next stage if they have failed to attain the pass mark for a particular module. A student may be allowed to carry up to 10 credits into a new stage. This policy is at the discretion of the examination board.
Indicative Syllabus
The following is a summary of the main topics included in this particular module: assessment of complaint data and market feedback, risk management, mandatory reporting (vigilance and medical device reports), and field actions (field safety corrective actions/advisory notices/recalls).
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Assignment written assignment | Coursework Assessment | Assignment | 60 % | Week 10 | 6 |
| 2 | Case Study workshop scenarios (formative) | Coursework Assessment | Assessment | 20 % | Week 12 | 3 |
| 3 | LAQ | Coursework Assessment | Open Book Exam | 20 % | Week 5 | 1,2,3,4,5 |
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Online Lecture | Not Specified | Lecture | 2 | Weekly | 2.00 |
Total Part Time Average Weekly Learner Contact Time 2.00 Hours
Required & Recommended Book List
Recommended Reading
2014-01-23 FDA Regulatory Affairs: Third Edition CRC Press
2014-01-23 FDA Regulatory Affairs: Third Edition CRC Press
FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.
The Third Edition of this highly successful publication:
- Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing
- Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL
- Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements
- Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V
- Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions
Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process thats broadly useful to both business and academia.
Module Resources
Non ISBN Literary Resources
| Book Cover | Book Details |
|
2014 FDA Regulatory Affairs: Third Edition CRC Press ISBN-10 ISBN-13 |
Journal Resources
| Book Cover | Book Details |
|
2014 FDA Regulatory Affairs: Third Edition CRC Press ISBN-10 ISBN-13 |
URL Resources
| Book Cover | Book Details |
|
2014 FDA Regulatory Affairs: Third Edition CRC Press ISBN-10 ISBN-13 |
Other Resources
None
Additional Information
None