Drug / Device Combination Products, module 12

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

No available dates

On location

English

12,600 DKK ex VAT

(app. 1,694 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. We also review updated EU legislation in relation to combination products (EU-MDR).

Focus is on EU and US regulations, but Chinese requirements are also touched upon.

In addition, you will gain insights into the approval of combination products containing software.

After the course, you are 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.


Key words

  • EU Directives for medical devices and drugs
  • Risk management
  • Usability and Human Factor (HFE) studies
  • Essential Performance Requirements (EPR)
  • Connected products for drug delivery and digital health
  • Quality assurance for medical devices (ISO 13485)


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Course leader(s) & Lecturer(s)

  • Pernille Skindhøj
    Course leader
    Senior Director, Regulatory Device
    Ascendis Pharma
  • Jannie Funch
    Lecturer
    Senior Regulatory Intelligence Manager, Regulatory Policy and Intelligence
    Novo Nordisk A/S
  • Martin Gabler
    Lecturer
    Associate Director
    Ferring Pharmaceuticals A/S
  • Ole Overgaard
    Lecturer
    Owner and Consultant
    Efficacy Aps
  • Jon Storm Madsen
    Lecturer
    Partner / Head of Usability Engineering
    Technolution
  • Claus Rømer Andersen
    Lecturer
    CEO, Consultant
    Rømer Consulting Aps
  • Holti Kellezi
    Lecturer
    VP, Digital Therapeutics
    Dawn Health
  • Tine Juul Zachariasen
    Lecturer
    Device Regulatory Affairs Specialist
    Novo Nordisk A/S
See all

IS THIS COURSE FOR YOU?

Sign up for this course if you already have some experience with medicine/product registration and want to learn about regulations for drug/device combination products.

What you will learn

  1. The basic principles of regulations on combination products in the EU (e.g. the new MDR legislation in Europe) and the US as well as insights into the Chinese rules.
  2. How to assess the problems that may arise during the 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 development projects for combination products.
  5. You also get 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, US, and China.
  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 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 also part of the examination syllabus.

Examination

The online exam is usually held 4-6 weeks after the course.

Course leader(s)

Pernille Skindhøj
Senior Director, Regulatory Device
Ascendis Pharma

Lecturer(s)

Jannie Funch
Senior Regulatory Intelligence Manager, Regulatory Policy and Intelligence
Novo Nordisk A/S
Martin Gabler
Associate Director
Ferring Pharmaceuticals A/S
Ole Overgaard
Owner and Consultant
Efficacy Aps
Jon Storm Madsen
Partner / Head of Usability Engineering
Technolution
Claus Rømer Andersen
CEO, Consultant
Rømer Consulting Aps
Holti Kellezi
VP, Digital Therapeutics
Dawn Health
Tine Juul Zachariasen
Device Regulatory Affairs Specialist
Novo Nordisk A/S

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WANT TO KNOW MORE OR NEED HELP?

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

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