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Management Forum

Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course

Practical guidance complex regulatory landscapes of EU and FDA for drug/device & device/drug combination products in this comprehensive course.

★★★★★ "It was a very good programme!"

17-18 September 2024
+ 21-22 January 2025, 19-20 May 2025, 10-11 September 2025 »

from £1099

Need help?  Enrol or reserve

Course overview

This course has been designed to provide regulatory affairs professionals with a deep understanding of the regulatory frameworks governing drug/device and device/drug combinations in the European Union and the USA.

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 course 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.

By the end of the course participants will have the knowledge and skills needed to navigate the complex regulatory landscape for drug/device and device/drug combinations in the EU and the USA effectively. They will be equipped to ensure compliance with the regulatory requirements and facilitate the successful development and commercialisation of these innovative products. 

PRE-SEMINAR READING - It is recommended that you have read the the EU Medical Device Regulation, particularly, Article 120 and the General Safety & Performance Requirements (Annex I) and Technical Documentation (Annexes II and III). For the US, review FDA’s Office of Combination Products website prior to attending this seminar.

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

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 need to understand the complex requirements applicable to medical devices incorporating ‘pharmaceutical’ ingredients, or pharmaceutical products incorporating a device or delivery system.

Enrol or reserve

The Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products course will cover:

Introductory Overview

  • Regulatory agencies in the EU and USA
  • Impact of the revision to the MDD
  • Transitional period from the MDD to the MDR
  • EU Regulatory reform proposals
  • EMA’s viewpoint management
  • Evolving regulatory landscape
  • Emerging trends

European Regulatory Guidance: Drug/Device and Device/Drug Combination Products

  • European regulatory framework for drug/device and device/drug combinations
  • Legal EU definitions of a drug/device and device/drug combination
  • Article 117: EU Requirements for Integral drug/device combinations
  • ‘In exclusive use with’
  • Other combinations – AI systems etc.

European Regulatory Guidance Continued

  • Risk management and compliance strategies
  • Interactions with regulatory agencies and stakeholders
  • Best practices for navigating the regulatory landscape

Defining the Regulatory Approval Pathway for your Product

  • Product classification
  • Differences between device containing ancillary medicinal substances and medicinal products
  • Responsibilities of regulatory affairs professionals in product development commercialisation

Medical Device CE Certification – Notified Body Expectations

  • CE marking process for medical devices
  • Devices containing ancillary medicinal substances
  • Post CE marking expectations and changes
  • Notified Body Opinion (NBOp)

MDR’s Impact on Medicinal Product Directive

  • Article 117

Documentation Requirements

  • Preparing regulatory submissions for drug/device and device/drug combinations
  • General Safety and Performance Requirements (GSPR) checklist

Clinical Trial Considerations

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

Product Information

  • Labelling requirements under the MDR
  • Labelling for combination products
  • Electronic Product Information (ePI)

Companion Diagnostics

  • Regulatory Considerations

UK Post Brexit

  • UK IRP: International Recognition Procedure

Pharmacovigilance for Combination Products: Vigilance of Pharmacovigilance

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

FDA’s Approach to Combination Products

  • Background and legal framework
  • Definitions of drug, biologics and medical device
  • "Borderline" issues and products (v. combination products)
  • Types of combination products
  • Primary mode of action and FDA's assignment algorithm
  • Jurisdiction and designation process 

FDA's Approach to Combination Products (continued)

  • Submission and regulatory pathways
  • Current GMP and quality system requirements
  • Post-market safety reporting requirements
  • Strategies for development and summary points

Enrol or reserve

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

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.

More details

Jonathan Hughes

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.

More details

Andrew Willis
San Salvatore Training Ltd

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.

More details

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

17-18 September 2024

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 14503

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 13 Aug

View basket 

Not ready to book yet?

for 7 days, no obligation

21-22 January 2025

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 15209

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 17 Dec

View basket 

Not ready to book yet?

for 7 days, no obligation

19-20 May 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15210

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 14 Apr

View basket 

Not ready to book yet?

for 7 days, no obligation

10-11 September 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15211

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 06 Aug

View basket 

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; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products 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

Apr 21 2016


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
  • Biodexa Pharmaceuticals (Wales) Limited
  • 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
  • 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
  • MatOrtho Limited
  • Meda Pharmaceuticals Limited
  • MedAlliance
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medtrade
  • 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


  • ALK-Abello A/S
  • Coloplast A/S
  • Coloplast AS
  • Danish Medicines Agency
  • Ferring Pharmaceutical A/S
  • 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
  • Novo Nordisk AS
  • PharmaIT
  • Takeda Pharma A/S
  • Xellia Pharmaceuticals AsP


  • Merck Group
  • Actelion Pharmaceuticals
  • Actelion Pharmaceuticals Ltd
  • Actelion Pharmaceuticals Ltd.
  • Anteis SA
  • Ares Trading 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


  • AbbVie Deutschland GmbH&Co.KG
  • benefits Regulatory Consulting
  • CSL Behring GmbH
  • Grunenthal GmbH
  • Medac GmbH
  • Merckle GmbH
  • Mylan Healthcare GmbH
  • Paul Hartmann AG
  • Pharmaceutical Research Associates GmbH
  • Roche Diagnostics GmbH
  • Sandoz International GmbH
  • Sanofi-Aventis Deutschland GmbH
  • Syntacoll GmbH
  • Vectura GmbH


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


  • Ayrton Saunders Limited
  • Genzyme Ireland Ltd
  • Janssen Pharmaceuticals
  • Sanofi
  • Sanofi Ireland
  • Shire Pharmaceuticals
  • Veryan Medical
  • Veryan Medical Ltd


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


  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • HALMED (Croatian Agency for Medicinal Products and Medical Devices)
  • HALMED - Croatian Agency for Medicinal Products and Medical Devices
  • PrimeVigilance


  • Astellas Pharma Europe BV
  • Biotop Medical
  • Merck BV
  • MSD
  • N V Organon
  • Sever Pharma Solutions


  • FAES Pharma SA
  • Ferrer Internacional S. A.
  • Grifols S.A
  • Grifols S.A.
  • Presspart Manufacturing


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


  • AstraZeneca
  • McNeil AB
  • Mölnlycke Health Care AB
  • Orexo AB

United States of America

  • AbbVie
  • Arthrex Inc
  • Glenmark Pharmaceuticals Inc.
  • IQVIA Biotech


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


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


  • 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


  • Cochlear Limited


  • Finnish Medicines Agency FIMEA

Korea, Republic Of

  • AJOU University


  • Alvogen Development Ltd.


  • Photocure ASA


  • 3M Poland Manufacturing

United Arab Emirates


Enrol or reserve

Run Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • 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:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, 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

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749