Presented by
Management Forum
Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course
Practical guidance on borderline Issues and combination products
★★★★★ "It was a very good programme!"
15-16 November 2023
from £1099
- Format: Live online
- 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.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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.
New
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
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
Eisai
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.
Tina Amini
Dr. Tina Amini, a pharmacist with PhD in Pharmaceutics. 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
JHRA Ltd
Jonathan Hughes, Ph.D., FTOPRA, has over 35 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.
Book Drug/Device and Device/Drug Combinations in the EU and USA Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
15-16 November 2023
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 12717
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 11 Oct
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Reviews of IPI's Drug/Device and Device/Drug Combinations in the EU and USA training course
It was a very good programme!
Nov 7 2022
Pia Malmberg 
Regulatory Affairs Specialist, Mölnlycke Health Care AB
Mar 10 2022
I am satisfied with presentation and content. It was useful to me.
Ines Jurač 
Head of Assessment of Quality Department, HALMED (Croatian Agency for Medicinal Products and Medical Devices)
Mar 10 2022
I am satisfied with presentation and content. It was useful to me.
Ines Jurač
Head of Assessment of Quality Department, HALMED (Croatian Agency for Medicinal Products and Medical Devices)
Nov 7 2022
Very good speakers, very well prepared presentations and contents adequate to the expectations.
Ricado Toribio 
Director of Global, Presspart Manufacturing
Nov 7 2022
Very precise wording and explanations were given on a complex subject
Sandra Thiolliere 
QA & RA Manager, Carthera
Mar 10 2022
Excellent - speakers were very, very knowledgeable, kept things interesting, lots of opportunity for questions..
Róisín Byrne 
Senior Regulatory Affairs Officer, Ayrton Saunders Limited
Mar 10 2022
Excellent - speakers were very, very knowledgeable, kept things interesting, lots of opportunity for questions..
Róisín Byrne
Senior Regulatory Affairs Officer, Ayrton Saunders Limited
Nov 1 2021
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
Apr 28 2021
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.
JooHee Kim 
Professor, AJOU University
Apr 28 2021
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
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
United Kingdom
- 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
- Blue Reg Pharma
- 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
- Kyowa Kirin International
- 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
- TEOXANE SA
Denmark
- ALK-Abello A/S
- Coloplast A/S
- Coloplast AS
- Danish Medicines Agency
- Ferring Pharmaceutical A/S
- Ferring Pharmaceuticals A/S
- KLIFO 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
- BAYER AG
- benefits Regulatory Consulting
- CSL Behring GmbH
- Grunenthal GmbH
- Medac GmbH
- Merckle GmbH
- Mylan Healthcare GmbH
- NSF PROSYSTEM GmbH
- Paul Hartmann AG
- Pharmaceutical Research Associates GmbH
- Roche Diagnostics GmbH
- Sandoz International GmbH
- Sanofi-Aventis Deutschland GmbH
- Syntacoll GmbH
- Vectura GmbH
France
- AIR LIQUIDE Santé International
- Alexion
- Carthera
- DBV Technologies
- Galderma International
- Guerbet
- Ipsen Limited
- Sanofi
- Servier International
- Voisin Consulting Life Sciences
Ireland
- Ayrton Saunders Limited
- Genzyme Ireland Ltd
- Janssen Pharmaceuticals
- Sanofi
- Sanofi Ireland
- Shire Pharmaceuticals
- Veryan Medical
- Veryan Medical Ltd
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.
Croatia
- Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
- HALMED
- HALMED (Croatian Agency for Medicinal Products and Medical Devices)
- HALMED - Croatian Agency for Medicinal Products and Medical Devices
- PrimeVigilance
- PRIMEVIGILANCE ZAGREB D.O.O.
Netherlands
- Astellas Pharma Europe BV
- Biotop Medical
- Merck BV
- MSD
- N V Organon
- Sever Pharma Solutions
Spain
- FAES Pharma SA
- Ferrer Internacional S. A.
- Grifols S.A
- Grifols S.A.
- INSTITUTO GRIFOLS SA
- Presspart Manufacturing
Israel
- Elcam Medical ACAL
- Ministry of Health
- Neuroderm
- Neuroderm.com
- TEVA
Sweden
- AstraZeneca
- BONESUPPORT AB
- McNeil AB
- Mölnlycke Health Care AB
- Orexo AB
United States of America
- AbbVie
- Arthrex Inc
- Glenmark Pharmaceuticals Inc.
- IQVIA Biotech
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
Australia
- Cochlear Limited
Finland
- Finnish Medicines Agency FIMEA
Korea, Republic Of
- AJOU University
Malta
- Alvogen Development Ltd.
Norway
- Photocure ASA
Poland
- 3M Poland Manufacturing
United Arab Emirates
- IPSEN
Run Drug/Device and Device/Drug Combinations in the EU and USA Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
