Medical Devices - Drug/Device Combinations

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

  • 12. Mar 2020

2 days course

English

11.500,- DKK ex VAT
(app. 1.546,- EUR ex VAT)

Module 12

Summary

On this course, you will learn about regulatory affairs within medical devices and drug/device combinations. You will learn the basic principles for development of medical device/medical device constituent part of a combination product. This will provide you with considerations and insights towards whether a medical device used in combination with a drug has to be registered according to the medical device- or the drug legislation.

In this module, we will focus our attention on legislative activities on the European market e.g. the new Medical Device Regulation, but also on the legislative requirements in the US. After the course, you will have the basic learnings on how to navigate in the borderline between drug and device legislation and offer regulatory strategic advice. This course is a part of our Regulatory Affairs Diploma and Master’s Program.

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 legislation in the EU and US
  2. The basic requirements when integrating a medicinal product in a medical device— either as an ancillary drug substance to a medical device or a drug product to be delivered by a medical device
  3. How to analyze and evaluate whether a combined product is to be regulated as a drug or as a medical device
  4. 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 legislations in the EU and US
  2. A regulatory professional who knows the basic requirements when integrating a medicinal product in a medical device — 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 can facilitate the analysis and evaluation of whether a combined product is to be regulated as a drug or as a medical device
  4. A regulatory affairs professional who can provide regulatory input to projects regarding development of combined products
Available start dates
Course dates: 12. Mar 2020, 13. Mar 2020

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 us at + 45 39 27 60 60, or send us an email at contact@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 and cannot attend the course, you may hand over the seat to a colleague, who will then have to register for the course on our website prior to course start. If the registration is closed, please send us full name, email, phone and title of your colleague to bfl@atriumcph.comRead our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

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

Send an email

 

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