Full Title Risk Management, Labelling and Promotion

Short Title Risk Mgmt, Labelling and Promot

Code REGU09009
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. It aims to provide students with a detailed knowledge and understanding of the labelling, sale and supply regulatory requirements for medical devices. The module also covers the application of risk management to medical devices.

Indicative Syllabus
The following is a summary of the main topics included in this particular module: Applicaton of Risk Management to medical devices; Medical device labeling and advertising regulations; product release, commercialization requirements; UDIs; individual country requirements;elabelling; social media; ethical and environmental issues.

Demonstrate an awareness of current issues impacting the medical device industry and understand ethical and philosophical issues attached to these.

Demonstrate they have knowledge of key environmental legislation applicable to the medical device industry. Evaluate and assess key environmental legislation relating to recycling issues and packaging of medical devices.

Learning Outcomes
On completion of this module the learner will/should be able to
  1. Demonstrate they have detailed knowledge and understanding of the content and application of ISO 14971: Medical devices - application of risk management to medical devices & risk management planning and the key components of a risk management file.

  2. Implement a risk management plan including risk analysis, risk evaluation, implemetation of appropriate risk controls and conduct a risk/benefit analysis.

  3. Communicate they have a detailed knowledge and understanding of the EU/US/Global legislation and regulations associated with medical device labelling and global perspectives on UDI, harmonised symbols, structure of IFU, intended use, contraindications, label / IFU review best practice , elabelling.

  4. Demonstrate they have a detailed knowledge and understanding of the legislation and regulations associated with medical device advertising and promotion from EU/US and Gobal perspective and also country specific requirements.

  5. Communicate a detailed knowledge of context of off label use/on label use and particular requirements for website content.

  6. Evaluate the relevance of social media (twitter, blogs..) and future directions for advertising and promotion. Evaluate the place of physician /customer contact and direct to consumer advertising in promotion strategy.

  7. Formulate and communicate judgements from a regulatory standpoint in each step of the risk management process and demonstrate ability to interact effectively with regulatory agents.


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 5,6,7 60 Week 8
Case Study workshop scenarios (formative) 4,5,6 20 Week 12
LAQ 1,2,3,4 20 Week 4


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
  • Clinical research and regulatory affairs: http://informahealthcare.com/loi/crr

Other Resources
None
Url Resources
Additional Info

ISBN BookList

Book Cover Book Details
Douglas W. Hubbard 2009 The Failure of Risk Management: Why It's Broken and How to Fix It Wiley
ISBN-10 0470387955 ISBN-13 9780470387955