Drug/Device and Device/Drug Combinations in the EU and USA

Practical Guidance on Borderline Issues and Combination Products

2-3 Apr 2020

& 24-25 Sep 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

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.

Programme day one

Chair’s welcome
Dr David Jefferys

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
    Dr Elizabeth Baker

Panel discussion

  • EU regulatory requirements

Defining the regulatory approval route for your product

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

Medical device CE certification – Notified Body expectations

Devices containing ancillary medicinal substance

  • Devices containing ancillary human blood derivative
  • Post CE marking expectations and changes
    Dr Tina Amini

Highlights of major differences in documentation between:

  • Device
  • Drug and device
  • Device and drug
    Dr Tina Amini

Quality and non-clinical considerations for combination products

  • Quality, pre-clinical and biocompatibility issues and how to address these for combination products
  • What kind of non-conformance can we expect if you combine a drug and device?
    Dr Tina Amini

Discussion session

Programme day two

Review of day one
Dr David Jefferys

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
    Dr David Jefferys

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 Mark Kramer
    Mark Kramer

Panel discussion

  • Compare and contrast EU and USA regulations

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 proposed regulation on medical devices
    Alison Wilson

Companion diagnostics

  • How the regulatory guidance impacts companion diagnostics
  • What to consider
    Dr David Jefferys

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
    Dr David Jefferys

Discussion session


David Jefferys (2-3 Apr 2020, 24-25 Sep 2020)

Dr David Jefferys is currently Senior Vice President with Eisai responsible for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia). After qualifying in medicine 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, joint CEO of MHRA. He was involved in the establishment of the European Medicines Agency, CPMP/CHMP member and MRFG and PER scheme chairman. For the last ten years he has worked in industry and chairs several key committees for ABPI, Efpia and IFPMA. He has lectured and published extensively in drug and device regulation and on benefit risk evaluation.

Elizabeth Baker (2-3 Apr 2020)

Dr Elizabeth Baker 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. She has been involved in all stages of the assessment of abridged, new drug and variation applications for medicinal products particularly those in the ophthalmic, dental, surgical and contact lens care categories. Prior to joining the MHRA she was at Pfizer Central Research from 1979.

Alison Wilson (2-3 Apr 2020)

Alison Wilson is an Independent Regulatory Affairs Consultant. Previously regulatory affairs manager for Smith & Nephew Wound Management, she has over 25 years’ experience of regulatory affairs in medicinal products, human tissue products and medical devices. She is a nominated UK expert for ISO (International Standards Organisation) TC150/WG 11 – Tissue Engineered Medical Products and a member of BSI Technical Panel RGM/1 – Regenerative Medicine.

Alison is a Module Advisor for the TOPRA* MSc in Regulatory Affairs (Pharma) (Module 9 – Biotechnology) and was Module Advisor for the MSc in Medical Technology Regulatory Affairs (Module 6 – Combination Products and Other Technologies) from 2006-2012. She is a member of the Topic Selection Panel for the MHRA Medical Device Technology Forum. She was a member of the MHRA (then MDA) working group responsible for production of the Code of Practice for Production of Human-Derived Therapeutic Products, 2002, and is the technical author for the BSI publication PAS 93: Characterisation of human cells for clinical application, published August 2011.

She is now Principal Consultant at CellData Service who provide strategic regulatory and development advice for a range of UK, EU and US clients seeking to develop and commercialise advanced therapy medicinal products (ATMPs), regenerative medicine therapies and drug-device combination products in the EU. She has extensive expertise in guiding smaller companies and academic groups through the regulatory complexities of development of novel regenerative medicine products, in particular scientific advice procedures and first-in-man clinical trials, and in recognition of this has received the first TOPRA Futures Award for contribution to regulatory science in new technology areas.

Andrew Willis (2-3 Apr 2020)

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

Tina Amini (2-3 Apr 2020)

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.

Book now

2-3 Apr 2020
2-3 Apr 2020 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
24-25 Sep 2020
24-25 Sep 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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  • Danish Medicines Agency
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  • Erydel S.P.A.
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  • Janssen Pharmaceuticals
  • JensonR+ Ltd
  • Leo Pharma A/S
  • MatOrtho Ltd
  • Medtrade Products Limited
  • Merckle GmbH
  • MSD
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  • Novella Clinical, a Quintiles Company
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  • Roche Diagnostics GmbH
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  • Sandoz International GmbH
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  • Vectura Delivery Devices Ltd

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

Well organised and would recommend to colleagues.

Roisin Slevin, Regulatory Affairs, Veryan Medical Ltd

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

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

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.

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

Cristina Stanca, Senior CMC specialist, Pharmedd Services Ltd

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

Aleksandra Pajić, Associate PV Project Manager, PrimeVigilance

Being new to the drug device area, the course gave a very good introduction to this field, with clear presentations and expert speaker(s) in the field.

Vasilios Dabouras, GRA CMC Manager , CSL Behring GmbH

Speakers were all skilled in their specific topic and easy to listen to.

Christina Adde, Director Regulatory CMC, Orexo AB

Comprehensive overview of the drug/device and device/drug regulations in Europe and the US. Very clear and engaging presentations given by speakers with a massive experience on the field. Highly recommendable to anyone interested on this topic.

Maria J Fernandez-Lozano, Senior Biologics Development Manager, Diamond BioPharm Limited

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

Very informed speakers with vast knowledge.

Christine Fogarty, Regulatory Site Officer (RSO), Sanofi

Excellent training with extremely knowledgable and effective speakers. Really feel like I learned a lot in two days.

Karen Ellis, Drug Safety Compliance Manager, Idorsia Pharmaceuticals Ltd

Excellent combination.

Kristiina Pellas, Senior Pharmaceutical Inspector, Finnish Medicines Agency FIMEA

Obviously [all speakers] have a broad experience (including world experience).

Andy Wydler, Senior R&D Program Manager, Actelion Pharmaceuticals

Very good, interesting, good to have different speakers.

Avital Levertov, Regulatory Affairs Manager, Elcam Medical ACAL

Great speakers, small audience which makes it easier to get in dialogue with the speakers

Liselotte Buron, Senior Manager, LEO Pharma A/S

Overall very good program that addressed my needs and gave a good introduction to the field. Very excellent speakers who were really knowledgeable within their field.

Maria Fullerton, Regulatory Senior Scientist, Lundbeck A/S

Overall very good

Arun Sarda, Global Director, QA & Regulatory Affairs, Presspart Manufacturing Ltd

Great location and speakers. Very professionally organised.

Sandra Item, Head RA & Knowledge Management, ISS AG, Integrated Scientific Services

Overall the course was very interesting, however the content seemed to focus more on the device/drug combination than the drug/ device combination which would have been of greater interest for me
there were several topics and information our company is not aware of, I believe that attending the course will help to avoid some mistakes with future submissions and post marketing

Juliane Mayerhofer, Int. Regulatory Affairs Manager, Octapharma Pharmazeutika Produktionsges.m.b.H

Very good speakers, well organised.

Anne Leresche, Manager, Merck Group 

The content was complete, presentation were well understanding and speaker were experts

Eva Marcon, Project Manager - Medical Device, DBV Technologies

Both the speakers and content were excellent. The quantity of information shared and the discussions they generated helped extend understanding of the subject into real world situations. If anything the speakers maybe needed slightly more time as the final presentations were slightly rushed.

Nicola Jordan, Senior Regulatory Specialist, Biocompatibles UK Ltd

Theresa Jeary's talks were very interesting and well structure. She has a deep knowledge.

Maria Jose Hijarrubia Ibrahim, Medical Devices Registers, Grifols S.A

I found this course very informative and helpful for my area of work, with speakers giving an in-depth yet concise review of each of the topics provided, in a relatively short time frame. Practical examples from the speakers’ experiences allowed a complete understanding of the topics even when these were outside of area of my practice.

Svetlana Agius, Senior Regulatory Affairs Specialist , Alvogen Development Ltd.

Good course

Cristina Cantù, NTC Srl

Overall good course- very useful information

Ranjith Palvai, Senior Regulatory Affairs Associate , JNJ

Very informative and engaging and enjoyable

Claire Whitley, Director, Allergan Ltd

The content of the course is particularly focused on regulatory requirements for a EU and US submission, the presentation were clear and the speaker were very open to discussion, as they tried to address all the question coming from the participants.

Ruben Agazzi, Scientist, Chiesi Farmaceutici S.p.A.

Very well organised and professional

Selenge Erdenechimeg, Quality Engineer, Pfizer Ltd

The course was well-organized and interactive. Speakers were knowledgeable in addressed topics within the course.

Fatima Zaid Abu Zanat, Regional Regulatory Affairs Head, IPSEN

Content and presentation was good, speakers mostly very good

Rose Le Doux, Quality Engineer, Pfizer Ltd

Useful starting point

Michael Ambuehl, Actelion Pharmaceuticals Ltd.

Worth time out of office. Well managed and organised day. Good content at level I could understand.

Laura Richards, Senior Researcher, MatOrtho Limited

Very useful but very intense course. Not for novices.

Steve Augustyn, Head of Mechanical Engineering, Team Consulting Ltd

A well delivered, practical course that would equip you with the knowledge to get a good understanding to market

Debbie East-Nuttall, Business Development Manager, LRQA UK

Content was good and speakers quite knowledgeable

Mandeep Singh, Senior Development Scientist, Biocompatibles, BTG

Nice, I would come to another training

Ahmed Abdullah Rajab, Saudi Food and Drug Authority


Agnieszka Studzinska, Clinical Group Coordinator, 3M Poland Manufacturing

Would recommend it to others, I liked the course

Theresa Larriba Harboe , Coloplast AS

Brilliant meeting with competent, knowledgeable and engaged speakers. I learned a lot

Christina Hansen, Head of Regulatory Affairs, Coloplast A/S