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) and approval of combination products containing software. Finally, you get an understanding of the development and risk analysis of medical devices in 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
- Connected products for drug delivery and digital health
- IVD used in clinical studies
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Course leader & lecturers
- Pernille SkindhøjCourse leaderSenior Director, Regulatory Device
Ascendis Pharma A/S - Josephine SparlundCourse leaderTeam Leader, RA Device Combination Products
Novo Nordisk 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 basic 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)
- Software as medical device (SaMD) & digital therapeutics – the link to connected devices
Day 2
- Drug/device combination products in the EU
- Drug/device combination products in the US
Day 3
- Clinical evaluations
- Design and development
- Product risk management for devices and combination products
- Navigating and merging risk-based approaches for combination products
- Usability Engineering
Registration
Registration deadline6 Nov 2024
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
Novo Nordisk A/S
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