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

Practical Guidance on Borderline Issues and Combination Products

18-19 Oct 2018

& 14-15 Mar 2019

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

Book now

Course overview

The demarcation between medicinal products and devices is becoming evermore important. In addition, with the convergence of emerging novel technologies the number of drug/device combination products and medical devices incorporating a medicinal substance are increasing. At the same time cell therapy and tissue engineered products are being combined with both pharmaceuticals and medical devices. This seminar will provide practical advice on the borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.

PRE-SEMINAR READING It is recommended that you have read the Medical Device Directives and the Essential Requirements Annex 1 & 3 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

Chairman’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
  • EMEAs viewpoint
    Dr. Elizabeth Baker


European Regulatory Guidance (continued)
Dr. Elizabeth Baker

Panel Discussion on the EU Regulatory Requirements


Defining the Regulatory Approval Route for your Product

  • Product Classification
  • Differences between Device containing ancillary medicinal substances and medicinal products
    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
    Tina Amini



Highlights of Major Differences in Documentation Between

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

Quality & Non-Clinical Considerations for Combination Products

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


End of day one

Programme - Day two

Review of day one
Dr. David Jefferys

Companion Diagnostics
Dr. David Jefferys

Clinical Trial Considerations
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



FDA’s Approach to Combination Products – (continued)
Mark Kramer



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



Post Market Surveillance for Combination Products: Vigilance or Pharmacovigilance?
Dr. David Jefferys


Close of meeting


David Jefferys (18-19 Oct 2018, 14-15 Mar 2019)

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 (18-19 Oct 2018, 14-15 Mar 2019)

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 (18-19 Oct 2018)

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.

Mark Kramer (18-19 Oct 2018, 14-15 Mar 2019)

Dr Mark Kramer, RAC, is President, Regulatory Strategies, Inc., a regulatory consultancy specializing in medical devices and combination products. He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration culminating in his position as Director of FDA’s Office of Combination Products from 2002 to 2007. From 2007-2010, he was Vice President, Regulatory Affairs and Chief Regulatory Strategist at GE Healthcare, where he had executive responsibility for US, Canadian and Latin American regulatory affairs for the medical device business.

He is on the Board of Directors of the Regulatory Affairs Professional Society (RAPS), served as Chair of the Wisconsin RAPS Chapter from 2007-2010, and is an adjunct faculty member for St. Cloud State University’s Master’s program in regulatory affairs.

Tina Amini (18-19 Oct 2018, 14-15 Mar 2019)

Tina Amini is a pharmacist with a PhD in Pharmaceutics from Aston University. She joined LRQA as Senior Technical Specialist recently after working at BSI, the Notfied Body as the lead Pharmaceutical Expert and Combination Product Speciaist.
Prior to joining BSI, Tina worked in the Pharmaceutical Industry for over 17 years in variety of disciplines. Her experience inlcudes, forumulation analytical work and process validation of a wide range of dosage forms taking products thorugh from discovery to commercialisation.

Book now

18-19 Oct 2018
18-19 Oct 2018 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
14-15 Mar 2019
14-15 Mar 2019 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

You may also be interested in

Previous customers include...

  • Anteis SA
  • Ares Trading SA
  • Cambridge Design Partnership
  • Chiesi Farmaceutici S.p.a.
  • Coloplast A/S
  • CSL Behring AG
  • Erydel S.P.A.
  • Glide Pharmaceutical Technologies Limited
  • Grifols S.A.
  • Guerbet
  • JensonR+ Ltd
  • McNeil AB
  • Menarini Ricerche
  • Merck Sharp & Dohme
  • MSD
  • Mundipharma Middle East FZ-LLC
  • NAMSA Medvance
  • NNE Pharmaplan A/S
  • NTC S.r.l.
  • PA Consulting Group
  • Philip Morris International
  • Sagentia
  • Sanofi-Aventis
  • Servier International
  • Team Consulting Ltd
  • TEVA
  • Vectura GmbH
  • Zambon S.p.A.

Great location and speakers. Very professionally organised.

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

Overall very good

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

Very good, interesting, good to have different speakers.

Avital Levertov, ‎Regulatory Affairs Manager , Elcam Medical ACA Ltd.

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

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.

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, , Grifols S.A

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 informative and engaging and enjoyable

Claire Whitley, Director - Urology, Neurology & CNS TA, Allergan Ltd

Very well organised and professional

Selenge Erdenechimeg, Quality Engineer, Pfizer Ltd

Overall good course- very useful information

Ranjith Palvai, Senior Regulatory Affairs Associate , JNJ

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

Dr. Fatima Zaid Abu Zanat, Regional Regulatory Affairs Manager, Mundipharma Middle East FZ-LLC

Good course

Cristina Cantù, , NTC Srl

Content was good and speakers quite knowledgeable

Mandeep Singh, Senior Development Scientist, Biocompatibles, BTG


Agnieszka Studzinska, Clinical Group Coordinator, 3M Poland Manufacturing

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

Would recommend it to others, I liked the course

Theresa Larriba Harboe , , Coloplast AS

Content and presentation was good, speakers mostly very good

Rose Le Doux, Quality Engineer, Pfizer Ltd

Nice, I would come to another training

Ahmed Abdullah Rajab, , Saudi Food and Drug Authority

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

Useful starting point

Michael Ambuehl, , Actelion Pharmaceuticals Ltd.

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

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