Summary
This three day course provides you with knowledge of regulatory affairs in relation to drug/device combination products. You learn how to handle the questions that arise in the development process of combination products and the input required to be part of the strategy.
Focus is on EU and US regulations, and we review the new EU legislation in relation to combination products (EU-MDR).
In addition, you get insights into the approval of medical devices for in vitro diagnostic (IVD). Finally, you get an understanding of the development and risk analysis of medical devices in combination products, as well as the interactions between drug and device during the development of combination products.
After the course, you will be able to offer your colleagues regulatory strategic advice in development projects, to collect relevant and sufficient documentation, and to search for relevant regulations in this area.
Other course participants say
"I got great value of the course and it was highly relevant to our company."
Kirsten Asser Larsen, Project Director, Biograil ApS
Keywords
- EU Regulations for medical devices and combination products
- Usability, risk analysis, and device development
- EU and US Classification of delivery systems
- IVD used in clinical studies
- Interactions between drug and device
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Course leader & lecturers
- Pernille SkindhøjCourse leaderSenior Director, Regulatory Device
Ascendis Pharma A/S - Ellen Nagato WatanabeCourse leaderDirector, Drug Product Formulation Development
Ascendis Pharma A/S - Tine Juul ZachariasenLecturerRegulatory Affairs Principal Specialist
Novo Nordisk A/S - Bo Kjellman BruunLecturerRegulatory Affairs Principal Specialist
Novo Nordisk A/S - Ulrik NøstedLecturerConsultant
Nøsted Medical Consulting - Martin GablerLecturerDirector Global RA Maternal Health & Medical Devices
Ferring Pharmaceuticals A/S - Pooja AbotiLecturerClinical Operations Lead
Novo Nordisk A/S - Josephine JensenLecturerSenior Human Factors Engineering Specialist, Device Development
Ascendis Pharma A/S
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Is this course for you?
Sign up for this course if you already have some experience with drug and product registration and wish to learn about regulations for device and drug/device combination products.
What you will learn
- The essential principles of regulations on combination products in the EU and the US. Including new legislation in Europe (MDR).
- How to assess the problems that may arise during development of a combination product.
- How to analyse and evaluate whether a combined product is covered by the regulations for medicines or medical devices.
- How to provide solid, regulatory input in combination product development projects .
- An introduction to digital combination products, both connected devices and applications.
What your company will get
- A regulatory employee who understands the basic principles of regulations on combination products in the EU and USA.
- A regulatory employee who can analyse and evaluate whether a combined product falls under the regulations for medicines or medical devices.
- A regulatory employee who understands the problems that may arise during the development of a combination product.
- A regulatory employee who can provide solid, regulatory input in projects where the development of combination products is in focus.
Course calendar
Day 1
- EU legislation for medical device
- General considerations of medical devices
- In vitro diagnostic regulation (IVD)
- Drug/device combination products in the EU
- Medical Device Registration in the US
Day 2
- Drug/device combination products in the US
- Usability Engineering
- Device Clinical Trials
Day 3
- Design and development
- Product risk management for devices and combination products
- Navigating and merging risk-based approaches for combination products
- Development of Combination Products with focus on interactions between drug and device
Registration
Registration deadline20 Jan 2026
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course, you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarise yourself with the mandatory readings before starting the course. The mandatory readings are part of the examination syllabus.
Examination
The online exam is usually held 4-6 weeks after the course.
Course leaders
Ascendis Pharma A/S
Ascendis Pharma A/S
Lecturers
Novo Nordisk A/S
Novo Nordisk A/S
Nøsted Medical Consulting
Ferring Pharmaceuticals A/S
Novo Nordisk A/S
Ascendis Pharma A/S
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10 Jun 2026
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Want to know more or need help?
Contact Educational Programme Leader Lone Rex at +45 20 62 11 46
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