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Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

Practical guidance on borderline Issues and combination products

29-30 Sep 2021

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Details

Course overview

The demarcation between medicinal products and devices is becoming ever more important and, with the convergence of emerging novel technologies, the number of drug/device combination products and medical devices incorporating a medicinal substance is increasing. At the same time, cell therapy and tissue-engineered products are being combined with both pharmaceuticals and medical devices. This seminar will address the European and FDA regulatory requirements, help you define the regulatory route for your product and offer practical guidance on Notified Body expectations, clinical trial considerations and post- market surveillance of borderline products. Participants will have an invaluable opportunity to discuss the complex issues involved with key regulatory experts in this field.

PRE-SEMINAR READING It is recommended that you have read the Medical Device Directive, Essential Requirements Annex 1 and 3 and the relevant sections on combination products in the new Medical Device Regulation prior to attending this seminar.

Why you should attend

BENEFITS OF ATTENDING

  • Understand the European regulatory guidance
  • Know what your competent authority expects
  • Gain an insight into notified bodies considerations on drug/device products
  • Learn how to define the approval route for your product
  • Clarify the major differences in documentation and approval routes
  • Consider quality systems requirements for combination products
  • Discover the FDAs regulatory approach to combination products
  • Hear how to deal with human tissue engineered products
  • Stay up-to-date on post market surveillance for combinations products.

Who should attend?

Development and regulatory personnel in the medical device, pharmaceutical and diagnostic industries, who are interested in medical devices incorporating ‘pharmaceutical’ ingredients, or pharmaceutical products incorporating a device or delivery system.

Presenter

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

29-30 Sep 2021
Live webinar
29-30 Sep 2021
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 18 Aug*
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 12 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...

  • 3M Poland Manufacturing
  • AIR LIQUIDE Santé International
  • ALK-Abello A/S
  • B Pierce Quality Solutions
  • Biocompatibles, BTG
  • Britannia Pharmaceuticals Ltd.
  • Centre of Evaluation for Product & Cosmetic
  • Chiesi Farmaceutici S.p.a.
  • CSL Behring AG
  • DBV Technologies
  • Elcam Medical ACAL
  • Foundation for Biomedical Research and Innovation
  • GW Pharmaceuticals
  • JNJ
  • KnowledgePool Group Ltd
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medicologic A/S
  • Medtrade Products Limited
  • Medtronic , Inc.
  • MSD International GmbH
  • NSF PROSYSTEM GmbH
  • Owen Mumford Ltd
  • Presspart Manufacturing Ltd
  • Research and Markets
  • Sagentia
  • Sanofi
  • Syntacoll GmbH
  • Takeda Pharma A/S
  • The European Medicines Agency (EMEA)
  • Vectura Delivery Devices Ltd

Overall very well presented and well thought out. [The speakers] were all very informative and provided very detailed information on the current regulations. A very interesting and worthwhile course.

Mary Day, GMP Medical Device Auditor, Chiesi UK Ltd, Apr 21

All very professional and experts in their field.
Very nice and informative webinar.

Chloë Scheldeman, R&D Manager Scientific Development, 2 Bridge, Sep 20

Good quality content, with hot topics, presented by engaging speakers.

Clara Desvignes, Senior Regulatory Scientist, Voisin Consulting Life Sciences, Sep 20

I am very pleased to attend this webinar. I think that the content is very interesting and the speakers explain themselves in a clear and understandable way.

Silvia Santano Hernandez, Regulatory Affairs Technician, Grifols S.A., Sep 20

The course accurately met my expectations with regard to content and quality – it was very good!

Brennan Miles, Senior Consultant, Team Consulting, Sep 19

All my expectations were met, including good venue and excellent organization! It was great to have so many expert speakers from regulatory agencies and notified bodies, which always makes a big difference. I particularly liked the competence of the speakers and their willingness to answer participants' questions, that it was a very interactive course, and that we received hard copies of the presentations.

Beate Schmidt, Consultant Regulatory Affairs, benefits Regulatory Consulting, Sep 19

Excellent delivery, very knowledgeable speakers and a great forum altogether. I wanted to gain an understanding of the quality and regulatory aspects of combined devices and I came away very pleased with the delivery, contents, and discussion we had during the course. I believe I am now equipped better to do my job as a quality engineer in a medical devices consulting company. I'd like to thank the speakers for sharing their expertise and experiences in such a graceful and professional manner.

Ana Burman, Quality Engineer, Team Consulting, Sep 19

The course was good and the presenters very experienced and knowledgeable.

Mina Patel, RA Manager, Medtrade Products Limited, Sep 19

A very comprehensive well presented course providing information on classifying combination products & issues to be considered when applying for a licence.

Sally Andrews, Head of Regulatory Affairs, Torbay Pharmaceuticals, Mar 19

Well organised and would recommend to colleagues.

Roisin Slevin, Regulatory Affairs, Veryan Medical Ltd, Mar 19

The speakers were very knowledgeable and willing to answers any question.

Ivona Murvaj, Senior PV Regulatory Associate, PRIMEVIGILANCE ZAGREB D.O.O., Oct 18

The course was well organized and the speakers were highly prepared. I had great insights on the overall process in terms of regulations, differences between FDA and EU as well as upcoming changes.

Valentina Squitieri, Senior Quality Manager, Idorsia Pharmaceuticals Ltd, Oct 18

The course was detailed and presented by individuals who had a wealth of experience within the industry. The information provided was concise and you did not feel overloaded with information. The presentations were delivered at a good pace.

Ashleigh Wilson, PDQA Associate, Teva NI ltd., Oct 18

Excellent training, I've received answers/advice to specific issues

Aleksandra Pajić, Associate PV Project Manager, PrimeVigilance, Oct 18

Well structured, good information, prepared speakers who answered all our questions.

Cristina Stanca, Senior CMC specialist, Pharmedd Services Ltd, Oct 18