Presented by
Management Forum

An Essential Overview of the Medical Device Industry - the Key Considerations

This short and concise webinar will provide the essentials of how medical devices and diagnostics are regulated. With changes being introduced this summer, this is an event you cannot afford to miss! 90 minute live webinar 14:00 (UK/London Time Zone)

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  • Format: Bespoke training
  • CPD: 1.5 hours for your records (depending on your requirements)
  • Certificate of completion

Overview

Highlighting the key information necessary to understand the regulation of medical devices and diagnostics.

During this 90 minute webinar, our expert speakers Dr David Jefferys and Theresa Jeary will discuss the key considerations, including:

  • What are medical devices and IVDs?
  • How will medical devices and IVDs be regulated in EU 27 under the new regulations?
  • What are Notified Bodies and how do they operate?
  • Combination Products
  • New controls in the UK as a result of Brexit

With changes in regulations coming this summer, this short and concise webinar should not be missed!

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

What are medical devices and IVDs?

How will medical devices and IVDs be regulated in EU 27 under the new regulations?

What are Notified Bodies and how do they operate?

Combination Products

New controls in the UK as a result of Brexit

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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We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

See below or contact us to discuss yor requirements.

UK

  • Clinigen
  • Dermal Laboratories
  • DIOMED DEVELOPMENTS (AEROPAK).
  • Sanofi

Greece

  • Elpen Pharmaceutical Co. Inc.

Romania

  • TEVA PHARMACEUTICALS SRL

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