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An Essential Overview of the Medical Device Industry Training Course

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.

★★★★★ "The presentations were very informative and both Theresa and David had made the course very interest... more (14)"

8 November 2024 »
from £549

Need help?  Enrol or reserve

Course overview

The concept of ‘Life Sciences’ is with us as we see the convergence of pharmaceuticals, medical devices and diagnostics. We are seeing the evolution of combination products, companion diagnostics, novel delivery systems, digital medicines and the introduction of artificial intelligence-enabled products. 

This training course has been designed to provide you with an up-to-date overview of the medical device industry, and will be beneficial for anyone working in the pharmaceutical industry who requires an understanding of the medical device sector and the interface between the two. It will also be beneficial for those new to medical devices and those who require a refresher on recent changes in this fast moving sector. 

How are the regulations changing?

What are the new rules for devices and diagnostics in the UK post-Brexit?

These key questions and many others will be answered by our experts in this focused programme and will provide an excellent opportunity to discuss the complexities involved. 

Benefits of Attending:

  • Gain a better understanding of the medical device industry
  • Be aware of the changing regulatory landscape
  • Lean about the evolving interfaces between pharmaceuticals and medical devices
  • Gain insights into the regulation of digital medicines
  • Learn the new rules for devices and diagnostics in the UK post-Brexit
  • Benefit from an opportunity for your questions to be answered 

 

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Who should attend?

This course is a must for:
•    Personnel from the pharmaceutical industry who want to learn more about the devices and diagnostic sectors
•    All those who want to understand the interface between devices and pharmaceuticals
•    Those who require a refresher on recent changes in the medical device sector

Enrol or reserve

This course will cover:

The Convergence of Pharmaceuticals, Medical Devices and Diagnostics

  • What is a medical device and an In-Vtiro Diagnostic (IVD)?  
  • How is the device market developing? 
  • The emergence of the ‘Life Science’ industry, digital medicine and AI-enabled products 
  • The challenges for regulation 

An Overview of the MDR and IVD Directives and the Regulations

  • Update on the MDR implementation
  • Update on the IVDR implementation

What are the Key Differences in Approach from Pharmaceuticals?

  • Who are the key players? 
  • The role of the Competent Authority and Authorised Representative

Notified Bodies

•    What is a Notified Body? 
•    How to work with a Notified Body 

How are Medical Devices and IVDs Evaluated?

•    What are the data requirements? 

Review and Summary of Role of Notified Bodies

  • How to work with Notified Bodies
  • Role in changes to the device post approval
  • Future developments for Notified Bodies 

Clinical Trial Requirements for Medical Devices

  • The control of trials for MDs and IVDs 
  • Phased introduction of the new EU system 
  • Controls for combination products 
  • Device and IVD Scientific Advice 

Medical Devices Vigilance versus Pharmacovigilance

  • The Regulatory System
  • Adverse event report - Vigilance
  • Post marketing surveillance 
  • User reporting systems 
  • Human factors requirements 

Device/Drug Combination Products and Companion Diagnostics

  • The Operation of Article 117 and Latest Guidance,  

Post Brexit MD and IVD controls in the UK

Future Changes, Influence of the Pharmaceutical Package, Role of the EMA, Regulation of Digital Devices and Global Harmonisation

Enrol or reserve

Theresa Jeary
BSI

Theresa Jeary is Principal Technical Specialist, Medicinal and Biologics, with BSi. 

Theresa holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person. She has over 25 years of 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 of Notified Body experience working at BSi as a technical expert and previously 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 is a frequently invited speaker on medical device legislation and combination products.

More details

David Jefferys
Eisai

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.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

8 November 2024

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 14007

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 04 Oct

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Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

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


The presentations were very informative and both Theresa and David had made the course very interesting. They are both very knowledgeable end experienced and delivered an excellent course.

Dec 2 2022

Lenka Elshouly
Administrative Assistant, The European Medicines Agency (EMEA)

May 21 2019

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.

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

United Kingdom

  • A.A. Thornton & Co
  • Advanced Healthcare Ltd
  • Bard Pharmaceuticals
  • Bard Pharmaceuticals Ltd
  • Bayer plc
  • Bayer Public Limited Company
  • Bells Healthcare
  • Bespak Europe Ltd
  • Convergence Pharmaceuticals
  • Dermal Laboratories
  • Dermal Laboratories LTD
  • 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
  • National Biofilms Innovation Centre
  • 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

France

  • IDA Ireland
  • IPSEN Pharma
  • Ipsen Pharma SAS
  • Université Paris Sud

Ireland

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

Netherlands

  • Astellas Pharma Europe B.V.
  • DADA Consultancy
  • The European Medicines Agency (EMEA)

Belgium

  • Toxikon Europe NV
  • UCB S.A.

Isle of Man

  • Panacea Pharma Projects
  • SEQ Limited

Switzerland

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

Denmark

  • Ferring Pharmaceutical A/S

Germany

  • Boehringer Ingelheim Vetmedica GmbH

United States of America

  • Rutgers Professional Science Master's Program

Enrol or reserve

Run An Essential Overview of the Medical Device Industry Live online for your team

1 day

Typical duration

Pricing from:

  • GBP 450
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, 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

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy