REGU09009 2019 Risk Management, Labelling and Promotion
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.
On completion of this module the learner will/should be able to;
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.
Implement a risk management plan including risk analysis, risk evaluation, implemetation of appropriate risk controls and conduct a risk/benefit analysis.
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.
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.
Communicate a detailed knowledge of context of off label use/on label use and particular requirements for website content.
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.
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.
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
• Adobe connect
• Microsoft office
• Multimedia including DVDs, webinars, youtube video clips, online videos
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.
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.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Assignment written assignment||Continuous Assessment||Assignment||60 %||Week 8||5,6,7|
|2||Case Study workshop scenarios (formative)||Continuous Assessment||Assessment||20 %||Week 12||4,5,6|
|3||LAQ||Continuous Assessment||Open Book Exam||20 %||Week 4||1,2,3,4|
Part Time Mode Workload
|Online Lecture||Not Specified||Lecture||2||Weekly||2.00|
Required & Recommended Book List
2009-04-27 The Failure of Risk Management: Why It's Broken and How to Fix It Wiley
ISBN 0470387955 ISBN-13 9780470387955
An essential guide to the calibrated risk analysis approach The Failure of Risk Management takes a close look at misused and misapplied basic analysis methods and shows how some of the most popular "risk management" methods are no better than astrology! Using examples from the 2008 credit crisis, natural disasters, outsourcing to China, engineering disasters, and more, Hubbard reveals critical flaws in risk management methods-and shows how all of these problems can be fixed. The solutions involve combinations of scientifically proven and frequently used methods from nuclear power, exploratory oil, and other areas of business and government. Finally, Hubbard explains how new forms of collaboration across all industries and government can improve risk management in every field. Douglas W. Hubbard (Glen Ellyn, IL) is the inventor of Applied Information Economics (AIE) and the author of Wiley's How to Measure Anything: Finding the Value of Intangibles in Business (978-0-470-11012-6), the #1 bestseller in business math on Amazon. He has applied innovative risk assessment and risk management methods in government and corporations since 1994. "Doug Hubbard, a recognized expert among experts in the field of risk management, covers the entire spectrum of risk management in this invaluable guide. There are specific value-added take aways in each chapter that are sure to enrich all readers including IT, business management, students, and academics alike" -Peter Julian , former chief-information officer of the New York Metro Transit Authority. President of Alliance Group consulting "In his trademark style, Doug asks the tough questions on risk management. A must-read not only for analysts, but also for the executive who is making critical business decisions." -Jim Franklin , VP Enterprise Performance Management and General Manager, Crystal Ball Global Business Unit, Oracle Corporation.
- Clinical research and regulatory affairs: http://informahealthcare.com/loi/crr
as per Moodle resources
as per Moodle resources