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

Training courses & Webinars:
Clinical

The objective of clinical studies is to ensure that all medical devices provide clinical benefits to the patient, as well as providing the necessary data to comply with current regulations. Our clinical training courses have been designed to provide delegates with the tools and techniques required to design and develop a medical device, as well as giving delegates an overview of the current regulatory landscape.

 

An Introduction to the Design and Development of Medical Devices Training Course

An Introduction to the Design and Development of Medical Devices

12-13 Oct 2020 - London
Also on: 14 Oct 2020

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Presented by David Howlett (bio)

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An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

11-13 Nov 2020 - Online webinar
Also on: 18 Nov 2020

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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Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

1-2 Dec 2020 - Online webinar
Also on: 3 Dec 2020

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Presented by Janette Benaddi (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

22-23 Sep 2020 - London
Also on: 24 Sep 2020

Practical guidance on borderline Issues and combination products

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

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FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course

FDA Approval Process for Medical Devices

14-15 Sep 2020 - London
Also on: 16 Sep 2020

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Presented by Jonathan Hughes (bio)

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

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

3-4 Nov 2020 - Online webinar
Also on: 5 Nov 2020

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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Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course

Managing Vendor/CRO/CMO Oversight

6-7 Oct 2020 - London
Also on: 8 Oct 2020

Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource

Presented by Laura Brown (bio)

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Medical Device Studies: Clinical Evidence Training Course

Medical Device Studies: Clinical Evidence

9-10 Nov 2020 - Online webinar
Also on: 10 May 2021

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Presented by Janette Benaddi (bio)
Robin Stephens (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

22-23 Sep 2020 - Online webinar
Also on: 23 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

19-20 Oct 2020 - Online webinar
Also on: 21 Oct 2020

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

I learned a lot and got some great insights into the process of design and development. It is an intense course with a lot of ground covered.

Damien Tackney, Reg Affairs, Ovelle Ltd

Wonderful speaker, friendly and approachable. He manages to put a lot of information over in a short period, in a simple way, making it a lot easier to digest. Overall, an amazing teacher and incredibly knowledgeable in regulations concerning medical devices. I particularly liked the interaction and encouragement of the group activities and communication. An amazing course, well structured, and a knowledgeable, friendly and approachable speaker.

Hannah Vince-Drew, Clinical Research Associate, Bedfont Scientific

Janette is excellent. Her knowledge and ability to clearly communicate in an engaging way about the topic at hand really mean that it's very easy to learn and understand what is being discussed. The workshops were very useful in cementing what you've learnt and also bouncing ideas around. Absolutely excellent, fantastic speaker, wealth of knowledge, discussion welcomed!

Alex Hyde, Senior Regulatory Affairs Specialist , Sinclair Pharma

Eveything perfect!

Katarzyna Paluszynska, Clinical Associate, EduBroker Sp.zo.o

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

Great overall. All topics of design control were covered well and I think everyone left with a better understanding than when they arrived. I have definitely applied some of the lessons we learned to my current role.

Emma Fairhall, R&D Manager, Leica Biosystems

The content is quite comprehensive, the presentation is clear and the speaker is very experienced. Both newbies and experienced people can benefit from this course, especially at the time of MDR transition.

Huajie Bu, Clinical Evaluations Manager, MED-EL Elektromedizinische Geräte GmbH

The speaker was very knowledgeable, able to answer all questions and allowed time for discussion of everyone's experiences. I learnt a lot and feel it was definitely worth the time.

Alice Sugden, Clinical Trials Submissions, AbbVie