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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.

23 May 2022

& 2 Nov 2022

Book now

Details

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.

Programme

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

Presenters

Theresa Jeary (More...)

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.

David Jefferys (More...)

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.

Book now

Book now

23 May 2022
Live webinar
23 May 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 18 Apr 22*
Enrol now
to attend
Live webinar
2 Nov 2022
Live webinar
2 Nov 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 28 Sep 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • A.A. Thornton & Co
  • Astellas Pharma Europe B.V.
  • Bayer plc
  • Bells Healthcare
  • Boehringer Ingelheim Vetmedica GmbH
  • F. Hoffmann-La Roche Ltd
  • Healthcare at Home Ltd
  • ICON plc
  • IPSEN Pharma
  • Irish Patents Office
  • ISIS Pharma Consulting Ltd
  • Meda Pharmaceuticals Limited
  • Medicines & Healthcare Regulatory Agency
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MHRA/NIBSC
  • Mylan
  • Norgine Ltd
  • Norgine Ltd.
  • Novartis Ireland Ltd
  • Pharmacovigilance Matters Limited
  • Quanticate
  • Red Line Pharmacovigilance Ltd
  • RWS Translations Ltd
  • Smith & Nephew Healthcare
  • Smith & Nephew plc
  • Teva Pharmaceuticals Ltd
  • TEVA UK
  • Toxikon Europe NV
  • Université Paris Sud
  • Veeva

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, May 19

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, Nov 17

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 17

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

Peter Davies, Quality Engineer, Bespak Europe Ltd, Nov 17

Very nice overview

Camiel Kulker, Senior Regulatory Affairs Manager , Astellas Pharma Europe B.V., Nov 17

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, May 17

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

Jovana Jevtic, Bard Pharmaceuticals Ltd, May 17

Just brilliant – speakers were so very knowledgeable

Valentina Curran, Senior Medical Affairs Executive, Norgine Ltd., May 17

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

Dolores Cassidy, Patent Examiner, Irish Patents Office, Nov 16

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 16

Good content

Anna Somuyiwa, Regulatory Affairs Consultant , Segulah Consulting Limited, Nov 16

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

Dolores Cassidy, Patent Examiner, Irish Patents Office, Nov 16