Drug / Device Combination Products, module 12

Learn how to secure regulatory approval of drug/device combination products

15 - 17 Nov 2023

or

13 - 15 Nov 2024

On location

English

19,500 DKK ex VAT

(app. 2,622 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

This 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.


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 Skindhøj
    Course leader
    Senior Director, Regulatory Device
    Ascendis Pharma A/S
  • Lasse Post Møller
    Lecturer
    Sr. RA Specialist, RA Digital Health & IVD
    Novo Nordisk
  • Jon Storm Madsen
    Lecturer
    Partner / Head of Usability Engineering
    Technolution
  • Martin Gabler
    Lecturer
    Associate Director
    Ferring Pharmaceuticals A/S
  • Ole Overgaard
    Lecturer
    Owner and Consultant
    Efficacy Aps
  • Tine Juul Zachariassen
    Lecturer

    Novo Nordisk A/S
  • Bo Kjellman Bruun
    Lecturer
    Regulatory Affairs Principal Specialist
    Novo Nordisk A/S
  • Helene Quie
    Lecturer
    Founder and CCO
    Atrium
  • Anni Clemens
    Lecturer
    Sr. Compliance Engineer
    Cook Medical
  • Vanessa Caldeira
    Lecturer
    Global Regulatory Lead, PhD
    Novo Nordisk A/S
See all

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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

  1. The basic principles of regulations on combination products in the EU and the US. Including new legislation in Europe (MDR).
  2. How to assess the problems that may arise during development of a combination product. 
  3. How to analyse and evaluate whether a combined product is covered by the regulations for medicines or medical devices.
  4. How to provide solid, regulatory input in combination product development projects .
  5. An introduction to digital combination products, both connected devices and applications.

What your company will get


  1. A regulatory employee who understands the basic principles of regulations on combination products in the EU and USA.
  2. A regulatory employee who can analyse and evaluate whether a combined product falls under the regulations for medicines or medical devices.
  3. A regulatory employee who understands the problems that may arise during the development of a combination product.
  4. A regulatory employee who can provide solid, regulatory input in projects where the development of combination products is in focus.

    Course calendar

    Choose your starting date
    Starting 15 Nov 2023
    Starting 13 Nov 2024
    15 Nov 2023 8:30-17:00
    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
    16 Nov 2023 8:15-16:20
    Day 2
    • Drug/device combination products in the EU
    • Drug/device combination products in the US
    17 Nov 2023 8:15-16:10
    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
    Practical information

    Related exams

    14 Dec 2023 10:00-13:00
    Go to exam page

    Registration

    Registration deadline
    1 Nov 2023
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    15 - 17 Nov
    13 Nov 2024 9:00-16:00
    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
    14 Nov 2024 9:00-16:00
    Day 2
    • Drug/device combination products in the EU
    • Drug/device combination products in the US
    15 Nov 2024 9:00-16:00
    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
    Practical information

    Related exams

    11 Dec 2024 10:00-13:00
    Go to exam page

    Registration

    Registration deadline
    6 Nov 2024
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    13 - 15 Nov
    Sometimes things change. This is the expected programme.

    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 leader

    Pernille Skindhøj
    Senior Director, Regulatory Device
    Ascendis Pharma A/S

    Lecturers

    Lasse Post Møller
    Sr. RA Specialist, RA Digital Health & IVD
    Novo Nordisk
    Jon Storm Madsen
    Partner / Head of Usability Engineering
    Technolution
    Martin Gabler
    Associate Director
    Ferring Pharmaceuticals A/S
    Ole Overgaard
    Owner and Consultant
    Efficacy Aps
    Tine Juul Zachariassen

    Novo Nordisk A/S
    Bo Kjellman Bruun
    Regulatory Affairs Principal Specialist
    Novo Nordisk A/S
    Helene Quie
    Founder and CCO
    Atrium
    Anni Clemens
    Sr. Compliance Engineer
    Cook Medical
    Vanessa Caldeira
    Global Regulatory Lead, PhD
    Novo Nordisk A/S

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    Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

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