Presented by
Management Forum

An Essential Overview of the Medical Device Industry

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

23 May 2022 + 1 more date

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  • Format: Live online
  • CPD: 6 hours for your records
  • Certificate of completion

Course overview

The medical device and diagnostics sectors are entering a period of regulatory change with implementation of the new Medical Device Regulation (MDR) in 2020. This interactive one-day course will provide you with the key information necessary to understand the regulation of medical devices and diagnostics, and to appreciate the key differences from pharmaceutical regulation. Our expert trainers will discuss the transition and implementation of the MDR and will cover the new rules and approaches to developing combination products. The important interface with digital technology will also be explored, alongside the impact of Brexit. There will be ample opportunity for discussion throughout the day to ensure you come away with a good understanding of the medical device industry.

Who should attend?

The course has been specifically designed to meet the needs of those working in pharmaceuticals and in allied business functions who need to understand the medical device sector. It will be particularly relevant for regulatory staff and those in clinical research, medical affairs and business development.

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The An Essential Overview of the Medical Device Industry course will cover:

What is a medical device and an IVD?

How is the device market developing?

An overview of the MDR and IVD Directives and the Regulations

  • Challenges of MDR implementation – May 2020
  • Preparation for IVDR implementation

What are the key differences in approach from pharmaceuticals?

Who are the key actors?

The role of the competent authority and authorised representative

Brexit update – impact on the medical device industry

What is a Notified Body?

How to work with a Notified Body

How are medical devices and IVDs evaluated?

What are the data requirements?

Clinical trial controls for devices

Device vigilance versus pharmacovigilance

Device/drug combination products and companion diagnostics

  • The operation of Article 117 and latest guidance

Building a global approval strategy on an EU CE mark approval

The key interface with digital technology

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Theresa Jeary

Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person. Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been involved in the development of many commercially available medicinal and medical device products.

She has over 10 years Notified Body experience working at BSi as a technical expert and until January held the position of Head of Notified Body at LRQA. Her area of technical expertise is in device-drug combinations and borderline classifications, and she has completed many successful consultations in this area with many European Competent Authorities and EMA.

Theresa now works as a consultant to the Pharmaceutical and Medical device sectors and is a frequently invited speaker on medical device legislation and combination products.

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David Jefferys

Dr David Jefferys is Senior Vice President for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia) at Eisai. After qualifying, he worked in clinical and academic medicine before spending 20 years as a senior regulator for both medicines and medical devices.

He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA and joint CEO of the MHRA. He was involved in the establishment of the European Medicines Agency, is a CPMP/CHMP member and Chair of the MRFG and PER scheme. For the last ten years he has worked in industry and chairs several key committees for ABPI,EFPIA and IFPMA.

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Book An Essential Overview of the Medical Device Industry Live online training

23 May 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11626

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 18 Apr

In your basket 

2 Nov 2022

Live online

00:00-00:00 UK (London) (UTC+00)
01:00-01:00 Paris (UTC+01)
20:00-20:00 New York (UTC-04)
Course code 11732

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 28 Sep

In your basket 

Reviews of IPI's An Essential Overview of the Medical Device Industry training course


Theresa was an excellent presenter. She presented her topic on regulatory submission and notified bodies really well. The content was clear and she had a good engagement with the delegates.

May 21 2019

Yulia Degtyareva
Scientist, Philips

Nov 23 2017

Both speakers were excellent and obviously knew their subject in great depth

Peter Davies
Quality Engineer, Bespak Europe Ltd

Nov 23 2017

Enjoyed the course, felt the topics were covered in enough detail given the subject matter. Informal atmosphere with a small number of delegates meant opportunity for questions which were welcomed. Both speakers were clearly passionate about their subject and this was evident during their presentations.

Gillian Hakewill
Regulatory Affairs Officer, SPD Development Company Limited

Nov 23 2017

The course was delivered by highly educated industry experts who shared their extensive knowledge in a clear and entertaining manner. The delegate numbers were small which allowed for a very personal service. I will be recommending Management Forum courses to my colleagues.

Stephanie Kirby
Senior Regulatory Affairs Officer, Bells Healthcare

May 19 2017

Just brilliant – speakers were so very knowledgeable

Valentina Curran
Senior Medical Affairs Executive, Norgine Ltd.

May 19 2017

The course material is very good. The speakers were excellent and the manner in which they presented.

Jovana Jevtic
Bard Pharmaceuticals Ltd

May 19 2017

The course is great for people having no idea about the medical device industry. Makes you understand the key differences between pharmaceuticals and medical devices in terms of regulations and vigilance.

Francois Rugiero
Convergence Pharmaceuticals

Nov 23 2017

Very nice overview

Camiel Kulker
Senior Regulatory Affairs Manager , Astellas Pharma Europe B.V.

May 19 2017

Well presented - clear and concise.

Paul Glennie
Project Manager, Napp Pharmaceuticals Ltd

Nov 11 2016

Good content

Anna Somuyiwa
Regulatory Affairs Consultant , Segulah Consulting Limited

Nov 11 2016

Did what it said on the tin - personally would like to see more of a marketing focus than regulatory but the day delivered what it promised.

Richard Addy
Senior Director, Customer Success, Veeva

Nov 11 2016

Excellent course, pitched at the right level for people new to this area of work.

Dolores Cassidy
Patent Examiner, Irish Patents Office

Nov 11 2016

Excellent course, pitched at the right level for people new to this area of work

Dolores Cassidy
Patent Examiner, Irish Patents Office

UK

  • A.A. Thornton & Co
  • Bard Pharmaceuticals
  • Bard Pharmaceuticals Ltd
  • Bayer plc
  • Bayer Public Limited Company
  • Bells Healthcare
  • Bespak Europe Ltd
  • Convergence Pharmaceuticals
  • Drug Safety Solutions Ltd
  • Healthcare at Home Ltd
  • ISIS Pharma Consulting Ltd
  • McKesson
  • Meda Pharmaceuticals Limited
  • Medicines & Healthcare Regulatory Agency
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MHRA/NIBSC
  • Mylan
  • Napp Pharmaceuticals Ltd
  • Newcastle University
  • Norgine Ltd
  • Norgine Ltd.
  • Pharmacovigilance Matters Limited
  • Philips
  • Proprietary Association Of Great Britain
  • Quanticate
  • Red Line Pharmacovigilance Ltd
  • RWS Translations Ltd
  • Segulah Consulting Limited
  • Smith & Nephew Healthcare
  • Smith & Nephew plc
  • SPD Development Company Limited
  • Teva Pharmaceuticals Ltd
  • TEVA UK
  • Veeva

Ireland

  • Abbott Diagnostics Division
  • ICON plc
  • Irish Patents Office
  • Novartis Ireland Ltd

France

  • IPSEN Pharma
  • Ipsen Pharma SAS
  • Université Paris Sud

Belgium

  • Toxikon Europe NV
  • UCB S.A.

Switzerland

  • F. Hoffmann-La Roche Ltd
  • TRB Chemedica International SA

Denmark

  • Ferring Pharmaceutical A/S

Germany

  • Boehringer Ingelheim Vetmedica GmbH

Isle of Man

  • Panacea Pharma Projects

Netherlands

  • Astellas Pharma Europe B.V.

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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