Vigilance of Medical Devices2020-02-04T11:04:11+00:00

Project Description

Vigilance of Medical Devices 

Course overview

Venue: Novotel London West Hotel, Hammersmith, London W6 8DR

Date: Wednesday 11 March 2020

With less than six months until full implementation of the Medical Device Regulations (MDR), there is still a lot of confusion amongst manufacturers about interpretation of the regulations and the practical implications. We have developed this training course to help address this uncertainty.

*Please note that the course dates and programme may be subject to change.

Who should attend?

Staff working in Quality Assurance, Regulatory Affairs, Post-market Surveillance, Vigilance, Device Safety, Drug Safety from both medical devices companies and pharma companies with drug device combinations.

Aims of course

  • To provide an overview of the Medical Devices Regulation (MDR)
  • To instil an in-depth understanding of Vigilance Reporting and Field Safety Corrective Actions under MDR
  • To ensure an understanding of Periodic Summary Reports
  • To explain how to handle vigilance for drug-device combination products
  • To support delegates’ learning by providing case studies from a large devices company

Learning Outcomes

On successful completion of this course delegates should be able to:

  • Demonstrate a good understand of the MDR as a whole
  • Provide an in-depth explanation of Vigilance Reporting and Field Safety Corrective Actions under MDR, as well as Periodic Summary Reports
  • Be able to explain how to handle vigilance for drug-device combination products

Key Topics

Programmed features:

  • Overview of the Medical Devices Regulation (MDR)
  • Vigilance reporting under MDR
  • Field Safety Corrective Actions under MDR
  • Periodic Summary Reports
  • Vigilance for drug-device combination products

Fees

£387 + VAT Academic

(Academic Units, Public Sector Organisations, Registered Charities)

Or

£595 + VAT Standard

(Standard Registration)

Registration fee includes lunch, refreshments and electronic access to all course materials.

Download Course Programme

Click here to download the programme

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Booking options

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Course Leader 

Fayez Abou Hamad – MD, PMS & Vigilance Expert 

Fayez Abou Hamad is MDR PMS and Vigilance leader at Terumo Europe in Belgium, as well as founder of “MDV-Solve” Medical Device Consulting Firm. He is a pharmacist with more than 15 years’ experience in quality assurance within the pharmaceutical and medical device industry and has expertise in Clinical evaluation, Risk management, PMS and Vigilance & MDR implementation.

Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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