Medicinal products intended for use in combination with a medical device is a category that poses additional regulatory challenges. With the implementation of the EU Medical Device Regulation (MDR), the requirements have become even more stringent.

This course provides an overview of the regulatory requirements for drug-device combination products, with a specific emphasis on the device perspective of combination products, tailored for individuals with a pharmaceutical background. The course is in English.

Target group

This course is for you with regulatory knowledge in the pharmaceutical field who want a better understanding of the device perspective of drug-device combination products and the requirements in the MDR. You work in for example regulatory affairs, quality assurance, or compliance for medicines administered using a medical device.

Objective

Upon completion of the course, the participant shall:

• Understand the EU regulatory framework for combination products.
• Have an overview of the development process for drug-device combination products.
• Understand the criteria for determining whether a product is regulated as a drug or device.
• Know the key authorities’ roles.
• Understand how to create compliant product documentation for various types of combination products, including:
  • Medical devices with ancillary medicinal substances
  • Medicinal products, whether single integral, non-integral, co-packed, or referenced.
• Gain insight into QMS principles and learn how to manage the QMS to ensure compliance with regulations for both drug and device procedures.
• Gain knowledge of EU vigilance requirements and the importance of accurate labeling.

Course contents

The course covers the following topics:

• Introduction to Drug-Device Combinations
• Combination Products in the EU
• Product Documentation
• Vigilance and Labelling
• Drug-Device Compatibility
• Corporate Quality Management

Subject experts

The course content has been developed together with subject matter experts from Prevas.

Course completion and certificate

This course is held in English. No prior knowledge is needed.

After registration, you have 6 months to complete the course. The course takes approximately 1-3 hours to complete, depending on your prior knowledge. Once all modules are marked as complete, you can download a personal course certificate.

Price

Single license: 240 € + VAT/per license

Group discounts

• 15% discount for groups of 5 or more participants. Use discount code 4YOU15. Group discount is calculated from normal price. 
• Larger group or unlimited organization access: Please request an offer here.

Please read the change and cancellation terms before registering under: Instructions for participants. Pharmaca reserves the right to make changes to the course.

We have expanded the registration features and sped up the invoice processing. In this training, you can use card payment and make group registrations. When using the promotional code, please check that the final price is correct. If you chose an invoice as the payment option, it will be generated automatically based on the information you provide. Please also add the PO number when registering. Please use the company search on the form as a priority.