EC Medical Devices Vigilance System and Post Marketing Surveillance

This conference provides a unique opportunity to meet Competent Authorities, Notified Bodies, Lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to Post Marketing Surveillance including Vigilance

Course Overview

Ensuring that a medical device remains safe and effective whilst on the market is an essential part of complying with the EU vigilance and post-marketing surveillance requirements outlined in the Directive 94/42/2 EC.

Competent authorities carry out market surveillance activities to certify that all devices comply with the latest regulations, ensuring that all devices in the market are safe for users. Post-marketing surveillance requires the manufacturer to monitor and review their devices to identify any need for corrective action. This activity is carried out in conjunction with authorised representatives, importers and distributors and is a key element of the manufacturer’s quality control system. It forms part of a PMS plan, which if carried out effectively can reduce the risk of adverse events. Manufacturers are then legally obliged, as part of a vigilance process, to report any serious incidents or correction measures to the relevant competent authorities.

Why you should attend

This seminar will give you practical advice on how to comply with the EU vigilance and post-market surveillance requirements. It will highlight manufacturers’ legal obligations and the risks associated with litigation, as well as providing essential guidance on how to report incidents in order to remain compliant. You will also gain practical advice and guidance on how to handle adverse event reporting during medical device clinical studies.

Attending these two days will offer you a unique opportunity to meet and network with Competent Authorities, Notified Bodies, lawyers, consultants and manufacturers to share good practice and experience.

Who should attend

This seminar will be of importance to all those involved in the medical device industry in the following roles and departments:

  • Regulatory affairs managers
  • Product safety managers
  • Post-market surveillance specialists
  • Global safety surveillance specialists
  • Vigilance managers
  • Pharmacovigilance co-ordinators
  • Pharmacovigilance associates
  • Report specialists
  • Manufacturing, registration, product safety, adverse event monitoring, regulatory affairs, distribution and all those interested in medical device vigilance in the European community

Programme day one

Chairmen’s Welcome and Introduction

Introduction to Post Marketing Surveillance
Tony Sant

In Depth Review of the EU Vigilance Process
Dr Ekkehard Stösslein


Application of the Reporting Rules
  • Case Studies
    Group Exercise led by Tony Sant and Dr Ekkehard Stösslein


Legal Aspects of Manufacturers Reporting Obligations
  • Main EU markets and US FDA
    Dr Grant Castle
Legal Aspects of FSCA
  • Product liability issues that might arise if one fails to take appropriate corrective action
  • The powers regulators have to act against products
    Dr Grant Castle


Field Safety Corrective Actions (FSCA): Expectations from Authorities
Dr Ekkehard Stösslein

Handling of Field Safety Corrective Actions (FSCA) – Industry Perspective
Janette Benaddi


Programme day two

Post Marketing Surveillance: an integral part of the QA system
  • Critical elements of risk Management, CAPA, PMS, Field Action SOPs
    Paul Sim

Role of Notified Bodies in vigilance
Paul Sim

Germany and vigilance:BfArM
  • Organisation
  • Handling of vigilance reports • National guidelines
  • Sharing of experiences
    Dr Ekkehard Stössleinn


UK and vigilance: MHRA
  • Organisation
  • Handling of vigilance reports • National guidelines
  • Sharing of experiences
    Tony Sant

Medical device regulation changes affecting PMS
Dr Ekkehard Stössleinn

Revision of vigilance guidelines:
  • Trending and FSN format
    Tony Sant

PMS and adverse event reporting during medical device studies
Janette Benaddi

Discussion and closing remarks

You may also be interested in

Adverse Event Management During Medical Device Clinical Studies on 28 January 2016

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

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Previous customers include...

  • Aerocrine AB
  • Alcon Laboratories SA
  • Beiersdorf AG
  • Biotop Medical
  • Boots UK Ltd
  • Boston Scientific Ltd.
  • Covidien (UK) Commerical Limited
  • Danish Medicines Agency
  • Elekta
  • Elekta Oncology Systems Ltd
  • ELLA - CS
  • Ferring Pharmaceutical A/S
  • Johnson & Johnson Medical Ltd
  • Medica Ad
  • Medimop Medical Projects Ltd
  • Medix Biochemica
  • Novo Nordisk A/S
  • Olympus
  • Olympus KeyMed Ltd
  • Oxoid Thermo Fisher Scientific Ltd
  • Roche Diabetes Care AG
  • Sinclair Pharma SRL
  • St Jude Medical UK Limited
  • Thermo Fisher Scientific Oy
  • Valeant
  • Varian Medical Systems UK Ltd
  • Winthrop Pharmaceuticals UK Ltd

Good breadth and depth of content. Too much unrelenting power point. The speakers were generally very good.

Kevin Buchanan, Senior Customer Quality Engineer, LifeScan

Excellent course, definitely recommended!

Lushendrie Naidoo, Quality Concerns Coordinator , Olympus KeyMed

Great job over all. Highly skilled speakers and highly relevant content.

Søren Møller Madsen, RA specialist, Radiometer Medical ApS

Course ran at a good pace to allow digestion of the information being presented. Good speakers who are obviously well educated in their subject matter.

Jon Brightwell, Quality Concerns Coordinator, Olympus KeyMed

I thought it was a very informative and comprehensive course given by knowledgeable speakers.

Gerrie ONeill, Snr Reg Affairs Specialislt, Boston Scientific

Interesting and good topics.

Bolette Duun-Christensen, RA Specialist , Radiometer Medical ApS

Good selection of speakers from very broad backgrounds. Particularly useful to have speakers from UK authorities.

Suna Horner, Associate Medical Manager, HRA Pharma UK & IE Ltd.

Professional, content perfect for attendees. Speakers were engaging and put a human face on the CA's and RB's.

Judy Grealish, Coronary PXM Engineering Supervisor, Medtronic

Overall it was good. Good level of detail.

Vikash Sarpal, Pharmacovigilance Associate, PharSafer

Very useful information provided by well qualified speakers.

Alison Etchells, Regulatory Affairs Officer, Thornton & Ross Ltd

Overall, really very good

Ben Rees, PV Team Lead, PharSafer Associates Ltd

Very good overall.

Claire Lacey, Regulatory Affairs Asssociate, Olympus Keymed

Overall the content was good

Claudio Colasante, Medical Events Specialist, Johnson and Johnson Vision

Very interesting training

Sonia Pinel, IBA

Well worth attending. I had a very enjoyable time and would be interested in different courses ran by yourself. It was interesting to have different perspectives on Vigilance and PMS.

Bryony Catt, Vigilance Specialist, Sinclair Pharmaceuticals Ltd

Each speaker is competent and open-minded for discussion. Lot of examples to help understanding. Open discussion

Maud Andriollo-Sanchez, Vigilance manager, TORNIER SAS - Wright Cie

Just the right content and duration.

John Hart, Head of Global Pharmacovigilance & EU QPPV, Besins Healthcare

Well structured with good experience represented

Katrine Dester, QA/RA coordinator, Contura International A/S