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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.

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The content, presenters and format of this course are customised to your requirements.

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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

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Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
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Previous customers include...

  • (MHRA) Medicines & Healthcare Products Regulatory Agency
  • ADVANCED MEDICAL OPTICS
  • Baxter AG
  • BD Saudi Arabia Office
  • BECKMAN COULTER
  • Biogen Idec Ltd
  • Boston Scientific
  • Boston Scientific Ltd
  • CIBA VISION
  • Dada Consultancy BV
  • European PharmInvent Services s.r.o.
  • Ewopharma International, s.r.o.
  • INAMED AESTHETICS
  • Johnson and Johnson
  • Medimop Medical Projects Ltd
  • Merck Sharp & Dohme
  • Novo Nordisk A/S
  • Olympus KeyMed Ltd
  • Orion Corporation
  • Owen Mumford Ltd
  • Oystershell Laboratories
  • Rayner Intraocular Lenses Ltd
  • Remote Diagnostic Technologies Ltd
  • Siemens AG
  • Sinclair Pharma SRL
  • St Jude Medical Sweden AB
  • TORNIER SAS - Wright Cie
  • Valtech Cardio
  • W.L. Gore and Associates
  • Wellspect Healthcare

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