Medical Devices - Drug/Device Combinations

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

No available dates

2 days course

English

11,200 DKK ex VAT
(app. 1,506 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

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

Hi! Do you need help choosing the right course?

We are ready to help you at +45 39 27 60 60 or contact@atriumcph.com

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IS THIS COURSE FOR YOU?

Whether you are new to the field or have several years of experience, this course is relevant if you are a Regulatory Affairs Professional who wants to improve your knowledge and skills.

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

Course information

Literature

Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize yourself with the mandatory readings before starting the course.

The mandatory readings are also part of the examination syllabus. 

Prerequisites

To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in regulatory affairs, or other equivalent qualifications. We consider all applications upon registration.

If you do not fulfill the requirements, you can still apply for the course if you have experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 20% of the positions on our course are filled by applicants who have no or limited experience in regulatory affairs. We consider applicants on a case-by-case basis.

Examination

The exam is usually held 4-6 weeks after the course. It is a digital exam, and you can therefore take the exam in your own country from any location that provides adequate internet access.

This course is a part of this programme

Regulatory Affairs Diploma

The regulatory affairs diploma gives you an understanding of the entire ‘regulatory affairs platform’ of the medicinal product lifecycle. All courses have been designed in collaboration with highly acclaimed experts, that are on our regulatory affairs faculty board

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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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