Combination Products for Pharma – Device Perspective, e-course

About the course

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.

Who should attend?

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.

Training goals

The training goal is to promote regulatory compliance for combination products by understanding the interaction between current legal requirements for medicinal products and medical devices.

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:

1.  Medical devices with ancillary medicinal substances
2. 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 content

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

Language: English

Subject experts

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