Presented by
Management Forum

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

Practical guidance on borderline Issues and combination products

1-2 Nov 2021 + 4 more dates

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  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

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.

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The Drug/Device and Device/Drug Combinations in the EU and USA course will cover:

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

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 

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

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

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

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1-2 Nov 2021
10-11 Mar 2022
7-8 Jun 2022
29-30 Sep 2022
14-15 Dec 2022

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.

More details

1-2 Nov 2021
10-11 Mar 2022
7-8 Jun 2022
29-30 Sep 2022
14-15 Dec 2022

Elizabeth Baker

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.

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1-2 Nov 2021
10-11 Mar 2022
7-8 Jun 2022
29-30 Sep 2022
14-15 Dec 2022

Tina Amini

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.

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1-2 Nov 2021

Jonathan Hughes

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.

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Book Drug/Device and Device/Drug Combinations in the EU and USA Live online/Classroom training

1-2 Nov 2021

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
05:00-13:00 New York (UTC-04)
Course code 11150

  • GBP 1,299
  • EUR 1,859
  • USD 2,098

In your basket 

10-11 Mar 2022

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 11609

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 03 Feb

In your basket 

7-8 Jun 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11861

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 03 May

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

29-30 Sep 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11706

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 25 Aug

In your basket 

14-15 Dec 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11862

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 09 Nov

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

Reviews of IPI's Drug/Device and Device/Drug Combinations in the EU and USA training course


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.

Apr 28 2021

Mary Day
GMP Medical Device Auditor, Chiesi UK Ltd

Sep 24 2020

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

Clara Desvignes
Senior Regulatory Scientist, Voisin Consulting Life Sciences

Sep 24 2020

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

Chloë Scheldeman
R&D Manager Scientific Development, 2 Bridge

Sep 24 2020

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 12 2019

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 12 2019

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 12 2019

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

Brennan Miles
Senior Consultant, Team Consulting

Mar 14 2019

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 14 2019

Well organised and would recommend to colleagues.

Roisin Slevin
Regulatory Affairs, Veryan Medical Ltd

Sep 12 2019

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

Mina Patel
RA Manager, Medtrade Products Limited

Oct 18 2018

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

Oct 18 2018

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

Cristina Stanca
Senior CMC specialist, Pharmedd Services Ltd

Oct 18 2018

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

Aleksandra Pajić
Associate PV Project Manager, PrimeVigilance

Oct 18 2018

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.

Apr 19 2018

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

Apr 19 2018

Excellent combination.

Kristiina Pellas
Senior Pharmaceutical Inspector, Finnish Medicines Agency FIMEA

Oct 18 2018

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

Oct 18 2018

Very informed speakers with vast knowledge.

Christine Fogarty
Regulatory Site Officer (RSO), Sanofi

Oct 18 2018

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

Christina Adde
Director Regulatory CMC, Orexo AB

Oct 18 2018

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 2018

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

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

Apr 19 2018

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

Andy Wydler
Senior R&D Program Manager, Actelion Pharmaceuticals

Nov 9 2017

Great location and speakers. Very professionally organised.

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

Nov 9 2017

Very good, interesting, good to have different speakers.

Avital Levertov
Regulatory Affairs Manager, Elcam Medical ACAL

Nov 9 2017

Overall very good

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

Nov 9 2017

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

Liselotte Buron
Senior Manager, LEO Pharma A/S

Nov 9 2017

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

Apr 24 2017

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

Apr 24 2017

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

Eva Marcon
Project Manager - Medical Device, DBV Technologies

Apr 24 2017

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

Apr 24 2017

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.

Apr 24 2017

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

Apr 24 2017

Very good speakers, well organised.

Anne Leresche
Manager, Merck Group 

Nov 17 2016

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.

Nov 17 2016

Very informative and engaging and enjoyable

Claire Whitley
Director, Allergan Ltd

Nov 17 2016

Overall good course- very useful information

Ranjith Palvai
Senior Regulatory Affairs Associate , JNJ

Nov 17 2016

Very well organised and professional

Selenge Erdenechimeg
Quality Engineer, Pfizer Ltd

Apr 21 2016

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

Laura Richards
Senior Researcher, MatOrtho Limited

Apr 21 2016

Content was good and speakers quite knowledgeable

Mandeep Singh
Senior Development Scientist, Biocompatibles, BTG

Nov 17 2016

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

Nov 17 2016

Good course

Cristina Cantù
NTC Srl

Apr 21 2016

Professional!

Agnieszka Studzinska
Clinical Group Coordinator, 3M Poland Manufacturing

Apr 21 2016

Useful starting point

Michael Ambuehl
Actelion Pharmaceuticals Ltd.

Apr 21 2016

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

Apr 21 2016

Nice, I would come to another training

Ahmed Abdullah Rajab
Saudi Food and Drug Authority

Apr 21 2016

Content and presentation was good, speakers mostly very good

Rose Le Doux
Quality Engineer, Pfizer Ltd

Apr 21 2016

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

Christina Hansen
Head of Regulatory Affairs, Coloplast A/S

Apr 21 2016

Would recommend it to others, I liked the course

Theresa Larriba Harboe
Coloplast AS

Apr 21 2016

Very useful but very intense course. Not for novices.

Steve Augustyn
Head of Mechanical Engineering, Team Consulting Ltd

UK

  • AbbVie Ltd
  • Allergan Limited
  • Allergan Ltd
  • Allergopharma
  • ApaTech Ltd
  • B Pierce Quality Solutions
  • Baxter
  • Bayer Healthcare
  • Besins Healthcare
  • Bespak
  • Bespak Europe Limited
  • Bespak Europe Ltd
  • Biocompatibles UK Ltd
  • Biocompatibles, BTG
  • Biogen Idec Inc
  • Biogen Idec Ltd
  • Bristows LLP
  • Britannia Pharmaceuticals Ltd.
  • Cambridge Design Partnership
  • Camurus AB
  • Catalent Pharma Solutions
  • Chiesi UK Ltd
  • CYTON BIOSCIENCES LTD
  • DCA Design International
  • DCA Design International Ltd
  • DePuy International Ltd, T/A DePuy CMW
  • Dermal Laboratories Ltd
  • Diamond BioPharm Limited
  • Emergo Consulting (UK) Ltd
  • Gilead Sciences
  • GlaxoSmithKline
  • Glide Pharmaceutical Technologies Limited
  • GSK
  • GW Pharmaceuticals
  • HRA Pharma
  • Iceblack
  • JensonR+ Ltd
  • JNJ
  • Knowledgepool Group Limited
  • LEO Pharma A/S
  • LRQA UK
  • MatOrtho Limited
  • Meda Pharmaceuticals Limited
  • MedAlliance
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medtrade Products Limited
  • Merck Group 
  • MSD International GmbH
  • NAMSA Medvance
  • Nerudia Limited
  • Novella Clinical, a Quintiles Company
  • Owen Mumford Ltd
  • PA Consulting Group
  • Pfizer Ltd
  • Pfizer R&D UK Ltd
  • Pharmalex UK Services Ltd
  • Pharmedd Services Ltd
  • Philips
  • Presspart Manufacturing Ltd
  • Roche Products Ltd
  • Sanofi
  • Sanofi-Aventis
  • Shire Pharmaceutical Ltd
  • Team Consulting
  • Team Consulting Ltd
  • TEVA Abbotts Park
  • Teva NI ltd.
  • TEVA Pharmaceuticals Europe BV
  • TEVA UK Ltd
  • The European Medicines Agency (EMEA)
  • Torbay Pharmaceuticals
  • Vectura Delivery Devices Ltd
  • Vectura Ltd

Switzerland

  • Merck Group
  • Actelion Pharmaceuticals
  • Actelion Pharmaceuticals Ltd
  • Actelion Pharmaceuticals Ltd.
  • Anteis SA
  • Ares Trading SA
  • BAXTER HEALTHCARE SA
  • CSL Behring AG
  • F. Hoffmann - La Roche Ltd.
  • Ferring International Center SA
  • Galderma SA
  • Geistlich Pharma AG
  • Hoffmann-La Roche
  • Idorsia Pharmaceuticals Ltd
  • ISS AG, Integrated Scientific Services
  • Medtronic , Inc.
  • Merck
  • MSD International GmbH
  • Philip Morris International

Denmark

  • ALK-Abello A/S
  • Coloplast A/S
  • Coloplast AS
  • Danish Medicines Agency
  • Ferring Pharmaceuticals A/S
  • LEO Pharma
  • Leo Pharma A/S
  • Leo-Pharma A/S
  • Lundbeck A/S
  • Medicologic A/S
  • NNE Pharmaplan A/S
  • Novo Nordisk
  • Novo Nordisk A/S
  • PharmaIT
  • ROWENA-CONSULTING
  • Takeda Pharma A/S
  • Xellia Pharmaceuticals AsP

Germany

  • AbbVie Deutschland GmbH&Co.KG
  • benefits Regulatory Consulting
  • CSL Behring GmbH
  • Grunenthal GmbH
  • Medac GmbH
  • Merckle GmbH
  • Mylan Healthcare GmbH
  • NSF PROSYSTEM GmbH
  • Pharmaceutical Research Associates GmbH
  • Roche Diagnostics GmbH
  • Sandoz International GmbH
  • Syntacoll GmbH
  • Vectura GmbH

France

  • AIR LIQUIDE Santé International
  • Alexion
  • DBV Technologies
  • Galderma International
  • Guerbet
  • Ipsen Limited
  • Sanofi
  • Servier International
  • Voisin Consulting Life Sciences

Italy

  • Chiesi Farmaceutici S.p.A.
  • Chiesi Farmaceutici SPA
  • CHIESI SPA
  • Erydel S.P.A.
  • Menarini Ricerche
  • NTC S.r.l.
  • NTC Srl
  • Zambon S.p.A.

Ireland

  • Genzyme Ireland Ltd
  • Janssen Pharmaceuticals
  • Sanofi
  • Sanofi Ireland
  • Shire Pharmaceuticals
  • Veryan Medical
  • Veryan Medical Ltd

Netherlands

  • Astellas Pharma Europe BV
  • Biotop Medical
  • Disphar International B.V.
  • Merck BV
  • MSD
  • N V Organon
  • Sever Pharma Solutions

Israel

  • Elcam Medical ACAL
  • Ministry of Health
  • Neuroderm
  • Neuroderm.com
  • TEVA

Spain

  • FAES Pharma SA
  • Ferrer Internacional S. A.
  • Grifols S.A
  • Grifols S.A.
  • INSTITUTO GRIFOLS SA

Sweden

  • AstraZeneca
  • BONESUPPORT AB
  • McNeil AB
  • Orexo AB

Austria

  • Baxter AG
  • Octapharma Pharmazeutika Produktionsges.m.b.H
  • Sandoz GmbH

Belgium

  • 2 Bridge
  • MSD (Europe), Inc
  • PhaRA BVBA

Malaysia

  • Centre of Evaluation for Product & Cosmetic
  • InQpharm Group Sdn Bhd
  • National Pharmaceutical Regulatory Agency (NPRA)

Saudi Arabia

  • Gulf Health Council
  • Saudi FDA
  • Saudi Food and Drug Authority

United States of America

  • AbbVie
  • Arthrex Inc
  • IQVIA Biotech

Croatia

  • PrimeVigilance
  • PRIMEVIGILANCE ZAGREB D.O.O.

Australia

  • Cochlear Limited

Finland

  • Finnish Medicines Agency FIMEA

Korea, Republic Of

  • Foundation for Biomedical Research and Innovation

Malta

  • Alvogen Development Ltd.

Norway

  • Photocure ASA

Poland

  • 3M Poland Manufacturing

United Arab Emirates

  • IPSEN

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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