Drug / Device Combination Products, module 12

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

16 Nov 2022

2 days course

English

11,234 DKK ex VAT
(app. 1,510 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.


Early Bird! Sign-up on 30 September 2022 at the latest to benefit from a reduced price. After 30 September 2022 the price is 12,600 DKK.


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)
Read more

Course leader(s) & Lecturer(s)

  • Pernille Skindhøj
    Course leader
    Senior Director, Regulatory Device
    Ascendis Pharma

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 calendar

Starting 16 Nov 2022
16 Nov 2022 8:30-17:30

Day 1

  • Introduction to the course
  • Introduction to drug/device borderlines and combination products
  • Medical Device EU Legislation
  • Stand-alone delivery systems
  • Medical Device EU legislation (continued)
  • Combination products regulated as medicines
  • Design and development
  • Product risk management for devices and combination products
  • Group work
  • Summary of day 1
17 Nov 2022 8:15-17:00

Day 2

  • Introduction to day 2
  • Usability and clinical evaluations
  • Drug/Device combination products in the US
  • Group Work
  • Connected delivery systems and digital health
  • Drug/Device combination products in China
  • Workshop: interactive session on how to use what you have learned
  • Summary of day 2
Practical information

Related exams

14 Dec 2022 10:00-13:00
Go to exam page

Registration

Registration deadline
2 Nov 2022
Atrium
Lersø Parkallé 101
2100 København Ø
Register
16 - 17 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 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

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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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