Course description
The development of drug-device combination products is one of the most complex challenges in today’s pharmaceutical and biotech industries. Organisations frequently face delays, submission questions, costly redesigns, and post-approval challenges due to misalignment between drug and device development, unclear regulatory pathways, and gaps in design control implementation.
This intensive two-day course provides a practical, end-to-end framework for developing combination products from early strategy through design controls, regulatory submission, approval, and lifecycle management. Drawing on real-world experience, the course highlights common failure points and provides actionable strategies and tools to help avoid them.
Through interactive workshops, case studies, and practical discussion, participants will learn what device expectations mean in a pharma-led development environment, how these expectations interface with medicinal product development, and how to build regulatory, technical, and quality strategies that support successful global approval.
