Medical Devices - Drug/Device Combinations

Learn about regulatory affairs within medical devices and drug/device combinations

  • TBD

1 day course

English

11.200,- DKK ex VAT
(app. 1.506,- EUR ex VAT)

At the moment there is no available dates for this course.

Module 12

Summary

On this course, you will learn about regulatory affairs within medical devices and drug/device combinations. You will get an understanding of how to consider the different topics that arise during the development of a combined product, which will enable you to judge whether a medical device used in combination with a drug has to be registered according to the medical device legislation or the drug legislation.

In this module, we will focus our attention on legal activities on the European market, but will also run a lecture on legal requirements in the US. After the course, you will be will able to offer regulatory strategic advice, compile adequate regulatory documentation and search for current and future regulations within the field.

Keywords

Drug/Device Borderlines and Combination Products
The Medical Device EU Legislation
The Medical Device EU Directive and the Drug EU Directive
Quality Management System for Medical Devices — ISO 13485
Product Risk Management for Medical Devices
Usability and Clinical Evaluations
Vigilance
Drug/Device Combinations in the US

What you will learn


  1. The basic principles of medical device regulations in the EU and US
  2. The basic requirements when implementing a medicinal product — either as an ancillary drug substance to a medical device or a drug product to be delivered by a medical device
  3. How to consider various problems arising during the development of a combined product
  4. How to analyze and evaluate whether a combined product is to be regulated as a drug or as a medical device
  5. How to provide proper regulatory input to projects regarding development of combined products

What your company will get

  1. A regulatory professional who understands the basic principles of medical device regulations in the EU and US
  2. A regulatory professional who knows the basic requirements when implementing a medicinal product — either as an ancillary drug substance to a medical device or a drug product to be delivered by a medical device
  3. A regulatory affairs professional who is able to analyze and evaluate whether a combined product is to be regulated as a drug or as a medical device
  4. A regulatory affairs professional who understands the various problems that can arise during the development of a combined product and who can provide proper regulatory input to projects regarding development of combined products

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call Carina Schaldemose Hansen, Digital Project Manager at + 45 39 15 09 22, or send her an email at csc@atriumcph.com.

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Senior Programme Director Tina Jensen at +45 39 15 09 14

Send an email

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