Our latest COVID-19 information - full Autumn programme of webinars now in place

Training courses & Webinars:
Vigilance

The vigilance and post marketing surveillance requirements of the regulations applicable to medical devices, is a mechanism for the UK, European and FDA regulatory agencies and manufacturers to identify and monitor adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner with patient safety as priority. Our training courses will provide participants with essential information to comply with the vigilance and post marketing surveillance requirements for medical devices.

 

An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

12-14 May 2021 - Online webinar
Also on: 19 May 2021

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

Presented by Janette Benaddi (bio)
Will Burton (bio)
Theresa Jeary (bio)

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Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

Drug/Device and Device/Drug Combinations in the EU and USA

26-27 Apr 2021 - London
Also on: 28 Apr 2021

Practical guidance on borderline Issues and combination products

Presented by Tina Amini (bio)
and 3 more leading experts

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EC Medical Devices Vigilance System and Post Marketing Surveillance Training Course

EC Medical Devices Vigilance System and Post Marketing Surveillance

26-27 Jan 2021 - Online webinar
Also on: 28 Jan 2021

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.

Presented by Janette Benaddi (bio)
Grant Castle (bio)
Ekkehard Stosslein (bio)

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Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

11-12 May 2021 - Online webinar
Also on: 13 May 2021

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

Presented by Stuart Angell (bio)
Nancy Consterdine (bio)

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Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

23-24 Feb 2021 - Online webinar
Also on: 25 Feb 2021

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Presented by Janette Benaddi (bio)

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New Medical Device Regulation Training Course

New Medical Device Regulation

15-16 Mar 2021 - London
Also on: 17 Mar 2021

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

Presented by Janette Benaddi (bio)
Theresa Jeary (bio)
David Jefferys (bio)

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The Medical Device Summer School - From Concept to CE Marking Training Course

The Medical Device Summer School - From Concept to CE Marking

5-9 Jul 2021 - London

*A practical five-day course with interactive workshops - now in its 17th successful year!*

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

Presented by Nick Baker (bio)
and 8 more leading experts

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The training was PHENOMENAL and I have learned so much regarding various topics in the field.

Anthony Hugill, Clinical Safety Specialist, Novocure

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

Excellent course which give a deep insight into the IVDR regulation without overloading with too much detail.

Jason Reece, CTO, Genomtec

Very knowledgeable speakers. The content was excellent, it is a difficult task to try and squeeze so much information into just three days!

Sarah Coverdale, Regulatory Affairs Specialist, Robinson Healthcare Limited

Janette was very knowledgable and enthusiastic and was able to keep the subjects interesting throughout the whole meeting. The content was very relevant.

Liselotte Borup, Clinical Trial Manager, Oticon Medical

The course gave me a good overview of the MDR and the reporting of adverse events: the content was good, the presentations were clear and the speaker was very good. She was open to questions, which she answered in the best way possible.

Valérie Jean, Senior Clinical Research Associate, Spineart SA

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

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

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

An enjoyable and insightful course. Good discussions and real-life examples and the exercises were worthwhile and interesting.

Tracey Jacob, Project Manager, Team Consulting