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EC Medical Devices Vigilance System and Post Marketing Surveillance Training Course

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.

26-27 Jan 2021

& 28-29 Jan 2021

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Details

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

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

Programme

Introduction to Post Marketing Surveillance

In Depth Review of the EU Vigilance Process

Application of the Reporting Rules

  • Case Studies 

Legal Aspects of Manufacturers Reporting Obligations

  • Main EU markets and US FDA

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

Field Safety Corrective Actions (FSCA): Expectations from Authorities

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

Post Marketing Surveillance: an integral part of the QA system

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

Role of Notified Bodies in vigilance

Germany and vigilance: BfArM

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

UK and vigilance: MHRA

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

Medical device regulation changes affecting PMS

Revision of vigilance guidelines

  • Trending and FSN

PMS and adverse event reporting during medical device studies

Presenters

Janette Benaddi (More...)

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.

Ekkehard Stosslein (More...)

Dr. Ekkehard Stösslein is a Senior Expert for Vigilance, Germany. He has many years experience in medical device regulations, particularly vigilance systems and post marketing surveillance in a leading position with a federal competent authority in Germany. He is an active member of the Medical Devices Coordination Group on Vigilance and was a member of the Study Group II of the Global Harmonisation Task Force.

Grant Castle (More...)

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.

Book now

Book now

26-27 Jan 2021
Live webinar
26-27 Jan 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 15 Dec*
Enrol now
to attend
Live webinar
28-29 Jan 2021
Face-to-face, (venue not yet confirmed)
28-29 Jan 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 17 Dec*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • BECTON DECKINSON
  • ABBOTT IRELAND
  • Abbott Vascular Devices Ireland
  • Allergan UK Limited
  • Arnold & Porter (UK) LLP
  • Becton Deckinson
  • Becton Dickinson
  • Besins Healthcare Pharma Services Ltd
  • Boston Scientific Ltd
  • Cook Medical
  • Gambro Lundia AB
  • Hospira UK Limited
  • INAMED AESTHETICS
  • Kimberly-Clark Corporation
  • Medtronic Ireland
  • Merck Sharp & Dohme
  • Mundipharma Research Ltd.
  • Novo Nordisk A/S
  • Oystershell Laboratories
  • Pfizer
  • Q-Med AB
  • Radiometer Medical ApS
  • Sanofi-Aventis R&D
  • Siemens Healthineers
  • ST JUDE MEDICAL
  • Teva Pharmaceuticals Industries Ltd
  • TORNIER SAS - Wright Cie
  • TYCO HEALTHCARE
  • Wellspect Healthcare
  • Wright Medical Technology Inc

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 20

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 20

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 20

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

Brigitta Lupsa, Marketed Product Support Team Leader, Owen Mumford Ltd, Jan 20

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

Søren Møller Madsen, RA specialist, Radiometer Medical ApS, Jan 19

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 19

Excellent course, definitely recommended!

Lushendrie Naidoo, Quality Concerns Coordinator , Olympus KeyMed , Jan 19

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 19

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

Gerrie ONeill, Snr Reg Affairs Specialislt, Boston Scientific, Jan 19

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 18

Very useful information provided by well qualified speakers.

Alison Etchells, Regulatory Affairs Officer, Thornton & Ross Ltd, Jan 18

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 18

Overall, really very good

Ben Rees, PV Team Lead, PharSafer Associates Ltd, Jan 18

Overall the content was good

Claudio Colasante, Medical Events Specialist, Johnson and Johnson Vision, Jan 18

Very good overall.

Claire Lacey, Regulatory Affairs Asssociate, Olympus Keymed, Jan 18