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

29-30 Jan 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

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


Janette Benaddi

Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she ahs also provided training to Notified bodies in this subject.

Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.

Ekkehard Stosslein

Dr. Ekkehard Stösslein is the Deputy Head of the Medical Devices Department and Head of the Active Medical Devices and IVD Section at the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn/Germany. Prior to the constitution of BfArM in July 1994 he was with the former Bundesgesundheitsamt (Federal Health Department), organizing the practical implementation of the Active Implantable Medical Device Directive in Germany. He is a member of the Medical Devices Experts Group on Vigilance and was a member of the Study Group II of the Global Harmonisation Task Force.

Grant Castle

Grant Castle is a Partner in the London office of Covington & Burling, practicing in food and drug regulatory law, with an emphasis on pharmaceutical and medical device regulation and associated data protection laws.
He has assisted clients with applications for the centralised approval of medicinal products, EC orphan drug designation, and with regulatory issues in the national approval process for medicines, including the EC mutual recognition procedure. He has participated in formal and informal good manufacturing practices (GMP), good clinical practices (GCP), advertising, borderline, drug safety and pharmacovigilance proceedings before the European Medicines Agency (EMEA), national authorities, courts and self-regulatory bodies. His litigation experience includes judicial review proceedings in the UK and EC courts, including the first challenge to a Community marketing authorisation for a medicinal product in the European Court of First Instance.
He received a BSc in Chemistry with first class honours from Imperial College of Science, Technology and Medicine in London in 1991 and a PhD in Organic Chemistry from Trinity College, University of Cambridge in 1994.
He has published extensively in the legal literature and has made several contributions to the technical literature in chemistry. He speaks and lectures frequently on pharmaceutical, medical device, data privacy and borderline products regulation at the Universities of Surrey and Wales, University of Cranfield, and business and professional groups in Europe and the U.S.

Paul Sim

Paul Sim, Regulatory Affairs Manager, BSi Group. Paul has worked in the healthcare industry for 34 years and is currently Project Managing BSI’s implementation of EU Commission Recommendation 2013/473/EU dealing with Unannounced Audits. Joining BSI in August 2010 leading the BSI effort working with the Saudi Food & Drug Authority on the implementation of the SFDA Medical Device Interim Regulations.

Previously he held senior RAQA leadership positions at Spacelabs Healthcare, Teleflex Medical, Smiths Medical, Ohmeda (formerly The BOC Group healthcare business)

Medical Device experience is across a very broad range of devices including: anaesthesia systems, patient monitors, vapourisers, ventilators, breathing circuits, single use sterile disposables and devices for re-use, infant warmers, incubators, steralisers, autoclaves, operating tables, infusion pumps and associated disposables, urinary catheters, surgical instruments, diagnostic cardiology etc.

Paul is a member of the Association of British Healthcare Industries (ABHI) Technical Policy Group and is Convenor of the ABHI ISO TC 210 Mirror Group. Convenor of the BSI Committee, which monitors all of the work undertaken by ISO TC 210, and Convenor of the BSI Sub-committee dealing with Quality Systems. As UK Delegation Leader to ISO TC 210, Paul is also actively involved in the work of national, European and international standards’ committees, dealing with revisions to the ISO 9000 series, ISO 13485, ISO 14971, ISO 15223 and others. He is Deputy Chairman and Council Member of Barema (British Anaesthetic & Respiratory Manufacturers Association), also a Member of the Association of Anaesthetists of Great Britain and Ireland (AAGBI) Safety Committee.

Tony Sant

Tony Sant is a Group Manager for MHRA’s Adverse Incident Centre and Biosciences and Implants specialist unit. He graduated in Physics at Imperial College, London and went on to obtain an MSc in Medical Physics and Medical Electronics at St Bartholomew’s Hospital. He joined one of MHRA’s precursors in 1985 from Medeci Medical Ltd. where he was employed as a medical electronics test engineer. At MHRA he has gained experience in: adverse incident investigation and incident systems development, quality systems auditing; medical device research and development, medical device evaluation project management, and general management of staff and other resources.
He has been instrumental in MHRA introducing and developing on-line reporting for users and manufacturers and was also closely involved in the development of SABRE MHRA’s Haemovigilance reporting system in 2005. He has been an active European representative of Study Group 2 (Adverse Events and Postmarket Surveillance) of the Global Harmonisation Task Force, where he led on guidance documents for electronic reporting of adverse incidents. He is an active member of the European Medical Device Experts Group on Vigilance and its sub-groups which recently revised the EU’s vigilance guidance and which currently are developing proposals for future comitology and recasting of EU medical device vigilance.

Book now

29-30 Jan 2019
29-30 Jan 2019 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Roche Diabetes Care GmbH
  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Alcon-Couvreur
  • Baxter AG
  • Baxter SAS
  • BD Medical - Diabetes Care
  • Becton Dickinson İth. İhr. Ltd. Şti.
  • Boots UK Ltd
  • Coloplast A/S
  • Dentsplysirona
  • ELLA - CS
  • Ferring Pharmaceuticals A/S
  • Gambro Bct Europe
  • Gambro Lundia AB
  • Genzyme Europe BV
  • Magstim
  • Medtronic
  • MSD Ltd
  • Perrigo
  • Procter and Gamble Technical Centres Ltd
  • Quintiles
  • Saudi Food and Drug Authority
  • Sinclair Pharma
  • Synthes GmbH
  • Valtech Cardio Ltd
  • Winthrop Pharmaceuticals UK Ltd
  • Zimmer GmbH

Overall, really very good

Ben Rees, Pharmacovigilance Coordinator, PharSafer

Overall the content was good

Claudio Colasante, Medical Events Specialist, Johnson and Johnson Vision

Interesting and good topics.

Bolette Duun-Christensen, RA Specialist , Radiometer Medical ApS

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 good overall.

Claire Lacey, Regulatory Affairs Asssociate, Olympus Keymed

Very useful information provided by well qualified speakers.

Alison Etchells, Regulatory Affairs Officer, Thornton & Ross Ltd

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.

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

Well structured with good experience represented

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

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, Trainee Vigilance Specialist, Sinclair Pharma

Very interesting training

Sonia Pinel, , IBA

Just the right content and duration.

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