Cross-functional development and lifecycle management of CPs; assess risks and interfaces
Learn how drug and device come together in development, approval, and lifecycle. Focus on risks, interfaces, and practical challenges across functions (i.e. EDDOs), with clear examples from EU and US regulatory expectations.
Drug–device combination products are products where a medicinal product and a medical device are combined into one system. These products are regulated differently across regions and require alignment across multiple functions.
In this course, you learn how development, regulatory, quality, clinical, and usability aspects interact across the lifecycle. You gain a clear overview of regulatory frameworks in the EU and US and understand how to apply them in practice.
You work with practical examples to understand common pitfalls and cross-functional risks. The course focuses on interfaces between drug and device, including risk management, usability, clinical validation, and submission responsibilities. It also introduces the role of clinically relevant performance considerations, including Essential Drug Delivery Outputs (EDDOs), in connecting device performance to clinical outcomes.
The course uses presentations, examples, and cross-functional discussions to support learning. It follows a high-level approach with focus on practical understanding rather than detailed regulatory depth.
At this course you will meet:
Javad Jabbari, Director, Global Regulatory Affairs, Ascendis Pharma
Casper Folsing, Director, Global Regulatory Affairs, Ascendis Pharma
Anja Skands, Vice President, Drug Product and Device Development, Hemab ApS
Claus Rømer Andersen, CEO & Technical Advisor, Rømer Consulting ApS
Morten Purup Andersen, Senior Human Factors Specialist, MGS Design & Development
Haya N.H. Pedersen, Clinical Development & Clinical Evaluation Expert, MedEvi Consulting
Rie Selchau Kallerup, Senior Manager & QA Commercial Drug Product & Finished Goods, Ascendis Pharma
