Introduction to Drug-Device combination products

Drug–device combination products are reshaping the pharmaceutical landscape. As medicinal products and medical devices become increasingly integrated, the traditional separation between drug and device development, formulation, and manufacturing is becoming less distinct.

But what defines a combination product—and why is it important to understand?

This network meeting, hosted by IDA Life Science in collaboration between the GMP & Compliance and the Medical Device SME groups, provides an introduction to key concepts within this area.

The programme consists of two 45-minute sessions, where Bolette Nordby and Pourya Vali will present a practical, high-level overview of relevant definitions, regulatory expectations, and key considerations when working with combination products.

The sessions will address:

• What characterises a drug–device combination product
• The need for cross-functional understanding
• Key regulatory and practical considerations
• The importance of early alignment across development, quality, regulatory affairs, manufacturing, and commercialization

The meeting is intended for professionals working within pharmaceuticals, medical devices, or related areas who are seeking a common starting point and shared terminology for working with combination products.

Following the presentations, there will be an opportunity for networking. Sandwiches will be served.

Make sure to unregister in case you can't participate. Otherwise you will be charged a no-show fee of 250 kr.