Full Title Post Market Surveillance

Short Title Post Market Surveillance

Code REGU09012
Level 09
Credit 05

Author Butler, Mary
Department Life Sciences

Subject Area Regulatory Affairs
Attendence N/A%
Fee

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.

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).

Learning Outcomes
On completion of this module the learner will/should be able to
  1. Demonstrate they have detailed knowledge and understanding of global statutory reporting requirements including local intepretation and current expectations with particular emphasis on EU and US requirements.

  2. Illustrate they have 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. Communicate a detailed knowledge and understanding of complaint management including assessment, evaluation and response to post market data.

  4. Demonstrate they have detailed knowledge and understanding of risk management principles and requirements including the role of detailed risk assessment in the evaluation and response to post market data.

  5. Illustrate they have detailed knowledge and understanding of requirements for all types of potential field actions including field safety corrective actions, advisory notices and recalls. This shall include an understanding of the critical components of effective field action management.

  6. Understand the links between CER and risk management and other documetation to proactively incorporate these into routine post market surveillance activities

  7. Analyse and evaluate post market surveillance data within a risk management process to achieve a lower risk/better product, e.g. data from US FDA MAUDE (Manufacturer and user facility device experience) database.

  8. Formulate and communicate a post marketing surveillance strategy which meets appropriate regulatory requirements.


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

Assessment Facilitites
Moodle access

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

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 100 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Assignment written assignment 6,7,8 60 Week 10
Case Study workshop scenarios (formative) 3,7,8 20 Week 12
LAQ 1,2,3,4,5 20 Week 5


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week


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
Online Lecture Not Specified Lecture 2 Weekly 2.00

Total Average Weekly Learner Workload 2.00 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
Independent Learning Online Independent Learning 5 Weekly 5.00

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book Resources

Other Resources
None
Url Resources
Additional Info

ISBN BookList

Book Cover Book Details
2014 FDA Regulatory Affairs: Third Edition CRC Press
ISBN-10 ISBN-13