Cross-functional development and lifecycle management of CPs: assessing risks and interfaces
Learn how drug and device components come together throughout development, approval, and lifecycle management. Focus on risks, interfaces, and practical cross-functional challenges (i.e., EDDOs), with clear examples from EU and US regulatory expectations.
About the course
Drug–device combination products are products in which a medicinal product and a medical device are combined into a single system. These products are regulated differently across regions and require alignment across multiple functions.
In this course, you will learn how development, regulatory, quality, clinical, and usability aspects interact throughout the product lifecycle. You will gain a clear overview of regulatory frameworks in the EU and the US and understand how to apply them in practice.
You will 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 with clinical outcomes.
The course uses presentations, examples, and cross-functional discussions to support learning. It follows a high-level approach, with a focus on practical understanding rather than detailed regulatory depth.
The course spans two days with an overnight stay, which provides time and space for reflection, immersion, and networking across participants—and thereby significantly enhances your overall learning outcomes.
In this course, you will learn how development, regulatory, quality, clinical, and usability aspects interact throughout the product lifecycle. You will gain a clear overview of regulatory frameworks in the EU and the US and understand how to apply them in practice.
You will 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 with clinical outcomes.
The course uses presentations, examples, and cross-functional discussions to support learning. It follows a high-level approach, with a focus on practical understanding rather than detailed regulatory depth.
The course spans two days with an overnight stay, which provides time and space for reflection, immersion, and networking across participants—and thereby significantly enhances your overall learning outcomes.
Target group
Professionals working with drug–device combination products across Regulatory Affairs, Quality, R&D, Clinical, and project leadership. The course is designed for participants with general regulatory knowledge who need a cross-functional understanding of combination products.
Why choose this course
Your benefits
- You understand drug–device combination products, including definitions, regulatory frameworks, and how development, risk management, usability, clinical validation, and submission responsibilities are connected across the lifecycle.
- You can distinguish between design validation, clinical validation, and human factors validation, and understand how clinically relevant device performance, including Essential Drug Delivery Outputs (EDDOs), links device design to clinical outcomes.
- You can identify cross-functional risks, understand interface challenges between constituent parts, and make informed, risk-based decisions to avoid common pitfalls throughout development and lifecycle management.
Your company's benefits
- Your employee gains a stronger organizational understanding of drug–device combination products, including regulatory frameworks and how development, risk management, usability, clinical validation, and submission responsibilities align across the lifecycle.
- Your employee gains an improved capability to interpret and apply different validation approaches, including design validation, clinical validation, and human factors validation, and to connect device performance, including Essential Drug Delivery Outputs (EDDOs), to clinical and regulatory expectations.
- Your employee gains a reduced risk of cross-functional gaps and interface issues, enabling more consistent, risk-based, and regulator-aligned decisions across development, submission, and lifecycle management.
Course programme
The course duration is 2 days. Accommodation is included.
- Definition, Classification, and Types of Combination Products
- Drug Development in the Context of Combination Products
- Medical Device Development and Design Controls
- Combination Product Risk Management
- Regulatory Frameworks: United States vs European Union
- Human Factors and Usability Engineering
- Clinical Development for Combination Products
- Quality Management Systems for Combination Products
- CMO and Supplier Management
- Lifecycle Management and Post-Approval Changes
- Post-Market Surveillance and Vigilance
Instructors
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Javad Jabbari, Director, Global Regulatory Affairs, Ascendis Pharma
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Casper Folsing, Director, Global Regulatory Affairs, Ascendis Pharma
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Anja Skands, Vice President, Drug Product and Device Development, Hemab ApS
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Claus Rømer Andersen, CEO & Technical Advisor, Rømer Consulting ApS
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Morten Purup Andersen, Senior Human Factors Specialist, MGS Design & Development
Register for the course
Course Navigating Drug–Device Combination Products (CP’s)
Format 2 days, overnight stay included
Price next year 18.100 kr. excl. VAT
Choose a date and sign up
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