ICH GCP R3 is now in English & EU languages. Book Now
  • Clinical PracticeClinical PracticeRight Arrow
  • PharmacovigilancePharmacovigilanceRight Arrow
  • ManufacturingManufacturingRight Arrow
  • Laboratory PracticeLaboratory PracticeRight Arrow
  • DistributionDistributionRight Arrow
  • Medical DevicesMedical DevicesRight Arrow
  • AI ClinicalAI ClinicalRight Arrow

About

An introduction to the principles of adverse event reporting and risk assessment as applied to medical devices in the US, Europe, and other key international markets. The US has the most developed device vigilance processes, but the course also summarizes the situation in Europe, Australia, Canada, and Japan. With coverage of risk assessment, AE report types, causality, and event types, this course is designed to give a solid grounding in all key aspects of vigilance within this $300+ billion sector.

The Device Safety and Vigilance course gives you a good understanding of the basic principles of vigilance and risk analysis. The course covers the history of device vigilance and safety, key components within adverse event reporting in the clinical and post-marketing settings, and an overview of signal detection and risk management. Keeping devices on the market without interruption becomes increasingly essential due to soaring development costs. Successful navigation of adverse event reporting, trend analysis, and risk assessment is key to product longevity, consumer confidence, and regulatory compliance. This module will provide you with a strong foundation of knowledge on device vigilance and safety.

Course Syllabus

  1. Learning Objectives for This Module

  1. History of Medical Device Reporting I
  2. History of Medical Device Reporting II
  3. History of Medical Device Reporting III
  4. History of Medical Device Reporting IV

  1. What Is Medical Device Reporting (MHRA Perspective)?
  2. Device Trials
  3. Pre-marketing ADEs
  4. Post-marketing ADEs
  5. FDA Requirement for MDRs
  6. Sources of MDRs I
  7. Sources of MDRs II
  8. Medical Device Report Types I
  9. Medical Device Report Types II
  10. Device Vigilance Definitions I
  11. Device Vigilance Definitions II
  12. MDR Reportable Events
  13. Acronyms Used for Device Safety

  1. The Device Vigilance Process
  2. Assessing Device Adverse Events
  3. Serious Adverse Events for Devices
  4. Examples of Life-Threatening Adverse Events I
  5. Examples of Life-Threatening Adverse Events II
  6. Intensity
  7. Serious vs. Severe
  8. Intensity and Seriousness – Question 1
  9. Intensity and Seriousness – Question 2
  10. Intensity and Seriousness – Question 3
  11. Intensity and Seriousness – Question 4
  12. Intensity and Seriousness – Answers I
  13. Intensity and Seriousness – Answers II
  14. Causality I
  15. Causality II – Difficulty in Establishing
  16. Causality III
  17. Causality IV – Classifications
  18. Causality V – Definitely Related
  19. Causality VI – Probably Related
  20. Causality VII – Possibly Related
  21. Causality VIII – Unlikely
  22. Lack of Efficacy
  23. Relationship Testing
  24. Unanticipated ADE
  25. Meaning of Anticipated

  1. Matrix of Global Safety Regulations
  2. US Postmarketing Requirements for Devices
  3. Requirements of FDA MDR Regulations
  4. Date of Awareness
  5. US Expedited Reporting I
  6. MDR Decision Tree
  7. US Reporting – Summary Matrix
  8. Malfunction Reporting
  9. US Reporting – Clinical Trials
  10. Alternative Summary Reporting
  11. European Expedited Reporting
  12. EU Criteria for Reporting
  13. Indirect Harm (EU Definition)
  14. European Reporting – Post-Marketing
  15. European Reporting – Clinical Trials
  16. New EU Regulations on Medical Devices
  17. Canadian Expedited Reporting
  18. Australian Expedited Reporting
  19. Japanese Expedited Reporting

  1. Customer Complaints
  2. Complaint Files – Procedure
  3. Customer Complaint, MDR, CAPA Flowchart
  4. Complaint Files – MDR I
  5. Complaint Files – MDR II
  6. MDR Reporting Requirement
  7. MDR 5-Day Report
  8. Non-MDR Complaints

  1. Trend Analysis
  2. Medical Device Safety and Risk Assessment
  3. US FDA National Medical Device Curriculum
  4. Risk Assessment – US
  5. Class of Device – US
  6. US Device Class I
  7. US Device Class II
  8. US Device Class III
  9. US Medical Devices Classification
  10. Class of Device (Ex-US)
  11. Risk Management
  12. Sample Trend Analysis I
  13. Sample Trend Analysis II – By Device Problem
  14. Sample Trend Analysis II – By Event Type
  15. Sample Trend Analysis II – By Remedial Action

Course Benefits

Benefits fully_compliant icon
Fully compliant

This course describes the compliance requirements for the reporting of adverse events relating to medical devices. Learners also receive 4 Continual Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

Benefits certification icon
Certified

All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.

Benefits affordable icon
Affordable

Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.

Benefits time_saving icon
Time-saving

Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.

Benefits reliable_and_trustworthy icon
Reliable and trustworthy

This course was written by Steve Jolley, a recognised expert in International drug and device vigilance. You will stay up to date with any international legislative changes in device vigilance as our training courses are constantly monitored, reviewed and updated (last updated in May 2018). Steve Jolley is a Cambridge University graduate with 25 years’ experience in drug & device safety & vigilance, who specializes in global safety compliance, business process improvement and signal detection. He is the Chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America and has worked with over 80 clients in the US, Europe and Japan. He is a featured speaker with the FDA and MHRA at DIA conferences and webinars on drug safety topics including auditing and signaling.)


Our Certified Customers

novartis
NHS
takeda
roche
dhl

Learner Rating & Reviews

4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

SM

I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...