REGU08011 2017 Introduction to Market Vigilance and Labelling

General Details

Full Title
Introduction to Market Vigilance and Labelling
Transcript Title
Market Vigilance & Labelling
Code
REGU08011
Attendance
N/A %
Subject Area
REGU - Regulatory Affairs
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2017 - Full Academic Year 2017-18
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SMEDI_L08 201900 Higher Diploma in Science in Science in Medical Device Regulatory Affairs and Quality
Description

This module introduces the students to labelling and post market requirements for medical devices. It aims to develop the students understanding of what a post market surveillance plan is and how to collect, analyse and respond to data on device safety and performance after market approval. It also aims to provide students with knowledge of the labelling requirements for medical devices.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Interpret and explain global statutory reporting requirements including local interpretation and current expectations

2.

Appraise post market surveillance requirements and requirement for development of a post market surveillance plan

3.

Evaluate the components of a complaint management including assessment, evaluation and response to post market data.

4.

Demonstrate knowledge of the requirements for all types of potential field actions including field safety corrective actions, advisory notices and recalls.

5.

Evaluate strategies for post market surveillance of medical devices in the US and EU.

6.

Communicate an 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, e labelling.

Teaching and Learning Strategies

Content will be delivered primarily via online and blended methods. Additional lecturing, as required, may be provided by outside specialists and practitioners. Learning strategies including evidence based and enquiry based learning also will be used.  Resources used will include Moodle, Adobe connect, Panopto, and other multimedia such as youtube, webinars, literature databases.

Module Assessment Strategies

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, group reports and essays and oral presentations.

Repeat Assessments

Repeat assignments will be given.

Indicative Syllabus

The following is a summary of the main topics included in this particular module:

complaint data and market feedback, mandatory reporting requirements (vigilance & medical device reports), and field actions such as field safety corrective actions/advisory notices or recalls. Medical device labelling regulations; UDIs; individual country requirements; e labelling.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Technical report Continuous Assessment Written Report 20 % Week 3 1,3,5,6
2 Essay Continuous Assessment Essay 30 % Week 6 2,3,5
3 MCQ/LAQ Continuous Assessment Multiple Choice 15 % Week 10 4,5
4 Critical evaluation Continuous Assessment Written Report 25 % Week 8 4,6
5 Presentation Continuous Assessment Oral Exam 10 % Week 13 3,6

Online Learning Mode Workload


Type Location Description Hours Frequency Avg Workload
Online Lecture Online Lecture 2 Weekly 2.00
Independent Learning Online Independent Learning 5 Weekly 5.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2011-04-07 Medical Device Design and Regulation Quality Press
ISBN 0873898168 ISBN-13 9780873898164

The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the MDDR Users Group on LinkedIn.

Recommended Reading
2015-08-18 Medical Devices: Regulations, Standards and Practices Woodhead Publishing

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices.

Based on the authors practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards.

  • Provides readers with a global perspective on medical device regulations
  • Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards
  • Includes a useful case study demonstrating the design and approval process

Module Resources

Non ISBN Literary Resources

as per book list

URL Resources

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

 

CFR Title 21: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.4

Guidance for Industry on General/Specific Intended Use: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073945.pdf