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

While the pre-market approval process has been delegated by most of the Competent Authorities to the private sector, Competent Authorities have kept the responsibility for the surveillance of their market. Because of this situation there is transfer of resource and energy to the monitoring of markets including the vigilance system within each Member State. The evaluation of incidents notified by manufacturers and users represents a key source of information for authorities, combined with sophisticated exchange of information between EU Member States, and with other countries like USA, Japan, Canada or Australia, provides a unique insight into the performance of devices in the post production phase.

Full compliance with the vigilance requirements laid down in Article 10 of Directive 93/42/EC is justified by the manufacturers’ legal obligations, risks associated to litigation and increasing scrutiny of Member States, but mainly by the ultimate objective of providing safe devices to patients. It is essential that manufacturers ensure compliance with these requirements.

This conference will provide practical advice on how to comply with these requirements including how to handle adverse event reporting during medical device clinical studies.

Why you should attend

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.

Who should attend

This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community.

Programme Day One

09.30 Chairman’s Welcome and Introduction Roland Gérard

09.40 Introduction to Post Marketing Surveillance Tony Sant

10.20 In Depth Review of the EU Vigilance Process Roland Gérard

11.00 Discussion

11.10 Coffee

11.30 Application of the Reporting Rules

  • Case Studies
    Group Exercise led by Roland Gerard, Tony Sant and Dr Ekkehard Stösslein

12.20 Discussion

12.30 Lunch

13.30 Legal Aspects of Manufacturers Reporting Obligations

  • Main EU markets and US FDA
    Dr Grant Castle

14.30 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

15.30 Discussion

15.40 Tea

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

16.30 Handling of Field Safety Corrective Actions (FSCA) – Industry Perspective
Roland Gérard

17.15 Discussion

17.30 End of Day One

Programme Day Two

09.00 Post Marketing Surveillance: an integral part of the QA system

  • Critical elements of risk Management, CAPA, PMS, Field Action SOPs
    Susanna Faria

09.30 Role of Notified Bodies in vigilance
Susanna Faria

10.20 Germany and vigilance:BfArM

  • Organisation
  • Handling of vigilance reports • National guidelines
  • Sharing of experiences
    Dr Ekkehard Stössleinn

10.45 Discussion

11.00 Refreshments

11.15 UK and vigilance: MHRA

  • Organisation
  • Handling of vigilance reports • National guidelines
  • Sharing of experiences
    Tony Sant

12.00 Medical device regulation changes affecting PMS
Dr Ekkehard Stössleinn

13.00 Lunch

14.00 Revision of vigilance guidelines:

  • Trending and FSN format
    Tony Sant

14.45 Refreshments

15.00 PMS and adverse event reporting during medical device studies
Janette Benaddi

16.00 Discussion and closing remarks

16.15 Close of conference

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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...

  • Allergan UK Limited
  • ALLTRACEL PHARMA LIMITED
  • Arnold & Porter (UK) LLP
  • Becton Dickinson İth. İhr. Ltd. Şti.
  • BIOCOMPATIBLES
  • Biomet UK Ltd
  • Boston Scientific Ltd.
  • COLIN EUROPE
  • Covidien (UK) Commerical Limited
  • Dentsplysirona
  • DePuy Johnson & Johnson
  • DISETRONIC MEDICAL SYSTEMS AG
  • Glycorex Transplantation AB
  • Johnson & Johnson Consumer Services EAME Ltd
  • MedPass International
  • Novo Nordisk A/S
  • Ortho-Clinical Diagnostics (Johnson & Johnson)
  • Oxoid Thermo Fisher Scientific Ltd
  • Pharmatek Consultancy Services
  • PharSafer
  • Procter & Gamble Technical Centres Ltd
  • Q-Med AB
  • Roche Diabetes Care AG
  • Sanofi Aventis
  • Sinclair Pharma
  • Swiss Medic
  • Terumo Europe NV
  • Thornton & Ross Ltd
  • TYCO HEALTHCARE
  • Valtech Cardio