Presented by
Management Forum

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.

Find out more

  • Format: Bespoke training
  • CPD: 12 hours for your records (depending on your requirements)
  • Certificate of completion

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

You may also be interested in

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 has 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.

More details

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.

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Tony Sant

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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.

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Ekkehard Stosslein

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We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

See below or contact us to discuss yor requirements.

Reviews of IPI's EC Medical Devices Vigilance System and Post Marketing Surveillance training course


The content was very good, the presentation was comprehensive and the speakers were knowledgeable and confident.

Jan 28 2020

Brigitta Lupsa
Marketed Product Support Team Leader, Owen Mumford Ltd

Jan 28 2020

All the speakers were absolutely excellent. I liked the fact that questions were invited and the chance to clarify with CAs and NB representatives.

Sarah Coverdale
Regulatory Affairs Specialist, Robinson Healthcare Limited

Jan 28 2020

Thoroughly enjoyable and highly recommended. This course gave me a great foundation for vigilance and for someone who does not have a vigilance background it was great to learn the basics and the processes. The course was very well organized, there were plenty of opportunities for engagement and the speakers were all very knowledgeable.

Pardeep Kaur Sidhu
Post Market Surveillance Specialist, Quality, BECTON DECKINSON

Jan 28 2020

The speakers were clearly very experienced people from the industry and it was a huge privilege to meet them in person. I can definitely say that I know more now than I did three days ago and I can utilize this knowledge in my work. Also, it was good to see and meet other candidates who were from different work background and the challenges they faced.

Pranil Patil
Regulatory Compliance Specialist, Becton Dickinson

Jan 29 2019

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

Gerrie ONeill
Snr Reg Affairs Specialislt, Boston Scientific

Jan 29 2019

Excellent course, definitely recommended!

Lushendrie Naidoo
Quality Concerns Coordinator , Olympus KeyMed

Jan 29 2019

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

Jan 29 2019

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

Søren Møller Madsen
RA specialist, Radiometer Medical ApS

Jan 29 2019

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

Kevin Buchanan
Senior Customer Quality Engineer, LifeScan

Jan 30 2018

Overall it was good. Good level of detail.

Vikash Sarpal
Pharmacovigilance Associate, PharSafer

Jan 30 2018

Overall, really very good

Ben Rees
PV Team Lead, PharSafer Associates Ltd

Jan 30 2018

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

Jan 30 2018

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.

Jan 30 2018

Interesting and good topics.

Bolette Duun-Christensen
RA Specialist , Radiometer Medical ApS

Jan 30 2018

Very good overall.

Claire Lacey
Regulatory Affairs Asssociate, Olympus Keymed

Jan 30 2018

Overall the content was good

Claudio Colasante
Medical Events Specialist, Johnson and Johnson Vision

Jan 30 2018

Very useful information provided by well qualified speakers.

Alison Etchells
Regulatory Affairs Officer, Thornton & Ross Ltd

Jan 24 2017

Just the right content and duration.

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

Jan 24 2017

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

Jan 24 2017

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

Jan 24 2017

Well structured with good experience represented

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

Jan 24 2017

Very interesting training

Sonia Pinel
IBA

UK

  • BECTON DECKINSON
  • Abbott Diagnostics
  • Abbott Laboratories Ltd
  • ADVANCED MEDICAL OPTICS
  • Advanced Sterilization Products
  • Allergan
  • Allergan UK Limited
  • Ansell (UK) Limited
  • Arnold & Porter (UK) LLP
  • Atlas Genetics Ltd
  • Azin Pharma Ltd
  • Bayer Healthcare
  • BD
  • BECTON DECKINSON
  • Becton Dickinson
  • Becton, Dickinson UK Ltd
  • Besins Healthcare
  • Biogen Idec Ltd
  • Biomet UK Ltd
  • Boston Scientific Ltd
  • BSI
  • Cardinal Health
  • CIBA VISION
  • Clinica
  • ConvaTec UK Ltd
  • Covance
  • Covidien (UK) Commerical Limited
  • Depuy CMW
  • DePuy International Limited
  • Dr Max Pharma Ltd
  • Elekta
  • Elekta Oncology Systems Ltd
  • Eli Lilly & Company Limited/Elanco Animal Health
  • Fresenius Medical Care Ltd
  • GlaxoSmithKline
  • GlaxoSmithKline plc
  • Hospira UK Limited
  • HRA Pharma UK & IE Ltd.
  • Johnson & Johnson Consumer Services EAME Ltd
  • Johnson & Johnson Medical Ltd
  • LifeScan
  • Lifescan Scotland
  • MAGSTIM CO LTD
  • MEDICINES & HEALTHCARE PRODUCTS RA
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MEDISENSE UK LTD
  • Microbiology R&D Laboratory - Oxoid
  • ML LABORATORIES PLC
  • MSD Ltd
  • Mundipharma Research Ltd
  • Novo Nordisk Ltd
  • Olympus Keymed
  • Olympus KeyMed Ltd
  • Ortho-Clinical Diagnostics (Johnson & Johnson)
  • Otsuka Pharmaceutical Europe Ltd
  • Owen Mumford Ltd
  • PA Consulting
  • Pfizer
  • Pfizer Ltd
  • Pharmatek Consultancy Services
  • PharSafer
  • PharSafer Associates Ltd
  • Procter & Gamble
  • Procter & Gamble Technical Centres Ltd
  • Procter and Gamble Technical Centres Ltd
  • Quintiles
  • QUINTILES CONSULTING - MTC
  • Rayner Intraocular Lenses Ltd
  • Remote Diagnostic Technologies Ltd
  • Robinson Healthcare Limited
  • Shire Pharmaceutical Ltd
  • Sinclair Pharmaceuticals Ltd
  • Smith & Nephew Wound Management
  • SSL INTERNATIONAL
  • St Jude Medical UK Limited
  • SUPPORT IN PHARMACOVIGILANCE LTD
  • The Boots Company
  • Thornton & Ross Ltd
  • Thornton and Ross Ltd
  • Tissue Science Laboratories PLC
  • Valeant
  • Varian Medical Systems UK Ltd
  • Vision RT Ltd
  • Winthrop Pharmaceuticals UK Ltd
  • Zimmer Limited

Belgium

  • Alcon-Couvreur
  • Baxter R&D Europe
  • Baxter World Trade SPRL/BVBA
  • Colgate-Palmolive R&D
  • Dentsplysirona
  • Gambro Bct Europe
  • Genae Associates NV
  • IBA
  • KYPHON EUROPE
  • Oystershell Laboratories
  • Oystershell NV
  • Perrigo
  • ST JUDE MEDICAL
  • Terumo Europe NV
  • TerumoBCT
  • TYCO HEALTHCARE
  • XCELLENTIS NV

Switzerland

  • BECKMAN COULTER
  • Becton Deckinson
  • Biosensors Europe SA
  • DISETRONIC MEDICAL SYSTEMS AG
  • Geistlich Pharma
  • Haag-Streit AG
  • Johnson and Johnson
  • MATHYS MEDICAL LTD
  • Obtech Medical Sarl
  • Roche Diabetes Care AG
  • Roche Diagnostics Ltd
  • Swiss Medic
  • Synthes GmbH
  • Vifor SA
  • Ziemer Ophthalmic Systems AG
  • Zimmer GmbH

Ireland

  • ABBOTT IRELAND
  • Abbott Medical Optics
  • Abbott Vascular Devices Ireland
  • ALLTRACEL PHARMA LIMITED
  • Athlone Laboratories Lrd
  • BIOCOMPATIBLES
  • Boston Scientific
  • Boston Scientific Ltd.
  • DePuy Johnson & Johnson
  • Health Products Regulatory Authority
  • INAMED AESTHETICS
  • Johnson and Johnson Vision
  • Medtronic
  • Medtronic Ireland

France

  • Abbott Spine
  • Baxter SAS
  • BD Medical - Diabetes Care
  • bioMerieux SA
  • BOSTON SCIENTIFIC INTL SA
  • COLIN EUROPE
  • Guerbet
  • HILL-ROM
  • Lifescan
  • MedPass International
  • Sanofi Aventis
  • Sanofi-Aventis R&D
  • TORNIER SAS - Wright Cie

Germany

  • Abbott GmbH & Co. KG
  • Bayer Pharma AG
  • Becton Dickinson
  • Beiersdorf AG
  • BSN Medical GmbH
  • Edwards Lifesciences Services GmbH
  • FERRING GmbH
  • Roche Diabetes Care GmbH
  • Roche Diagnostics GmbH
  • Sanofi-Aventis Deutschland GmbH
  • Siemens AG
  • SIRO Clinpharm Germany GmbH
  • Stryker

Netherlands

  • Aurobindo Pharma B.V.
  • Baggerman Farma Consult
  • Biotop Medical
  • BOSTON SCIENTIFIC INT HOLDING LTD
  • Dada Consultancy BV
  • Genzyme Europe BV
  • Interdos Pharma BV
  • Mentor Medical Systems B.V.
  • Merck Sharp & Dohme
  • Nobel Biocare
  • Omron Healthcare Europe BV
  • Schering-Plough

Denmark

  • 3Shape
  • Ambu A/S
  • Coloplast A/S
  • Contura International A/S
  • Cook Medical
  • Danish Medicines Agency
  • Ferring Pharmaceutical A/S
  • Ferring Pharmaceuticals A/S
  • Neurodan A/S
  • Novo Nordisk A/S
  • Radiometer Medical ApS

Sweden

  • Aerocrine AB
  • Agfa Healthcare
  • Gambro Lundia AB
  • Glycorex Transplantation AB
  • Q-Med AB
  • St Jude Medical Sweden AB
  • St Judes Medical AB
  • Wellspect Healthcare

Israel

  • Bio-Technology General (Israel) Ltd
  • ColBar LifeScience Ltd.
  • Medimop Medical Projects Ltd
  • Teva Pharmaceuticals Industries Ltd
  • Valtech Cardio
  • Valtech Cardio Ltd

Italy

  • Di Renzo SRL
  • Diasorin S.p.A
  • Orthofix Srl
  • Recordati S.p.A
  • Sinclair Pharma SRL
  • Terumo Europe

United States of America

  • ARROW INTERNATIONAL INC
  • Kimberly-Clark Corporation
  • Siemens Healthineers
  • W.L. Gore and Associates
  • WL GORE & ASSOCIATES INC
  • Wright Medical Technology Inc

Finland

  • Medix Biochemica
  • Orion Corporation
  • Thermo Fisher Scientific Oy
  • Tieto Oyj

Austria

  • Baxter AG
  • Baxter Innovations GmbH
  • MED-EL Medical Electronics

Czech Republic

  • ELLA - CS
  • European PharmInvent Services s.r.o.
  • State Institute for Drug Control

Norway

  • Luzmon Medical
  • Luzmon Medical AS

Saudi Arabia

  • BD Saudi Arabia Office
  • Saudi Food and Drug Authority

Bulgaria

  • Medica Ad

Croatia

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

Korea, Republic Of

  • Korea Health Industry Development Institute (KHIDI)

Portugal

  • Infarmed

Serbia

  • Medicines and Medical Devices Agency of Serbia

Slovak Republic

  • Ewopharma International, s.r.o.

Spain

  • Alcon Laboratories SA

Turkey

  • Becton Dickinson İth. İhr. Ltd. Şti.

United Arab Emirates

  • Becton Dickinson B.V.

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy