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

Practical guidance on borderline Issues and combination products

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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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


  • 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.


Introductory overview

  • Background
  • Life cycle management
  • Exclusivity
  • Patents
    Dr David Jefferys

European regulatory guidance

  • Life expectations of a competent authority
  • Impact of the revision to the MDD
  • EMA’s viewpoint management

Defining the regulatory approval route for your product

  • Product classification
  • Differences between device containing ancillary medicinal substances and medicinal products

Medical device CE certification – Notified Body expectations

  • Devices containing ancillary medicinal substance
  • Devices containing ancillary human blood derivative
  • Post CE marking expectations and changes

MDR’s Impact on Medicinal Product Directive

Documentation Requirements

Clinical trial considerations

  • How the regulatory pathway for the final marketed product determines the clinical trial regulations to be followed
  • Clinical Trials Directive 2001/20/EC – medicines
  • Requirements for clinical development of medical devices
  • Clinical data requirements and post-marketing surveillance

Companion diagnostics

  • How the regulatory guidance impacts companion diagnostics
  • What to consider

FDA’s approach to combination products

  • Requirements for product assignment, pre-market review and post-market regulation
  • Good manufacturing practice (GMP) regulation
  • Resources and guidance documents
  • Hints and tips on good approaches 

Post-market surveillance for combination products: vigilance or pharmacovigilance?

  • Understanding the differences between medical device vigilance and pharmacovigilance
  • How to handle the challenges posed by combination products
  • Pharmacovigilance reporting
  • Device vigilance reporting

Human tissue-engineered products

  • What are tissue-engineered and advanced therapy combination medicinal products?
  • How are these new borderline products regulated in the EU and US?
  • What are the practical challenges with development of these products?
  • Impact of the Medical Devices Regulation


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.

Elizabeth Baker (More...)

Elizabeth is Group Manager, Licensing Group 1 and Drug/Device Enquiries, MHRA. The unit has responsibility for advising on the drug/device borderline, advising on regulatory aspects of drug/device combinations, and undertaking the assessment of data on the medicinal aspects of these combinations on which the MHRA is consulted by Notified Bodies. Prior to joining the MHRA she was at Pfizer Central Research from 1979.

Tina Amini (More...)

Dr. Tina Amini, a pharmacist with PhD in Pharmaceutics, is Director of Medical Device Division at NDA Group. She has over 30 years experience in Pharmaceutical and Medical Devices. She previously held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at bsi Notified Body, where she was responsible for Device Drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management System (QMS) as the lead auditor.

Tina has extensive experience of regulatory expertise for CE marking of medical devices, and has been involved in the classification of borderline products and consultation process with several EU competent authorities and EMA for device/drug products.

Prior to joining Notified Bodies, Tina worked in the Pharmaceutical Industry in a variety of disciplines where she took products through from discovery to commercialisation.

Jonathan Hughes (More...)

Jonathan Hughes, Ph.D., FTOPRA, has over 32 years of worldwide regulatory and clinical affairs experience across medical devices, drug / biologic – device combination products and in-vitro diagnostics. He has worked with medical device and pharmaceutical companies, both large and small, across multiple locations to help develop and execute regulatory strategies for market clearance, approval and access.

Jonathan has hands-on experience in a variety of therapeutic areas and has worked across different technologies and types of medical products including medicated devices (devices containing ancillary drug and biologic constituents), drug delivery systems and componentry, sterile and non-sterile disposables and durable equipment, in-vitro diagnostics, software controlled devices and standalone software (including mobile apps). He has experience of regulating medical devices and combination products across most international markets including the European Union, US, Japan, China, Canada and Australia.


Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 10-11 Mar 2022
  • 7-8 Jun 2022
  • 29-30 Sep 2022
  • 14-15 Dec 2022

Book now

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  • Actelion Pharmaceuticals
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  • B Pierce Quality Solutions
  • Bespak Europe Ltd
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  • Camurus AB
  • Chiesi Farmaceutici SPA
  • Coloplast A/S
  • DePuy International Ltd, T/A DePuy CMW
  • Ferring Pharmaceuticals A/S
  • Galderma SA
  • Gulf Health Council
  • Idorsia Pharmaceuticals Ltd
  • LEO Pharma
  • MatOrtho Ltd
  • Medicologic A/S
  • Neuroderm
  • Novella Clinical, a Quintiles Company
  • Novo Nordisk
  • Sagentia
  • Sanofi-Aventis
  • Saudi Food and Drug Authority
  • Servier International
  • Vectura Delivery Devices Ltd
  • Vectura GmbH
  • Veryan Medical

10 out of 10! Loved the polling option - it kept me engaged.. Presentations were very helpful and informative.

Angelina Barfield, Director, Safety Reporting, IQVIA Biotech, Nov 21

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

It was good to study various things overseas about drugs, medical devices, and drug combinations.
It has been beneficial for an important project we are currently working on.

Elise Kim, Researcher, Foundation for Biomedical Research and Innovation, 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