First-Principles Safety & Effectiveness Engineering for Combination Products

Apply the first-principles safety and effectiveness confidence framework to the integrated development and lifecycle management of combination products, including the justified reuse and bridging of platforms, prior knowledge, and evidence.

Challenges

Real-world challenges addressed

Pre-market regulatory issues
Fragmented drug and device development
Human factors gaps
Weak integration of pharmaceutical development, QbD, design controls, and risk management
Constituent-part and supplier changes
Platform reuse and bridging rationale
Justification of prior evidence for new products or configurations
Scale-up and technology-transfer challenges
Lifecycle and post-market issues

Events

First-Principles Safety & Effectiveness Engineering for Combination Products Workshop

A workshop dedicated to the First-Principles Safety & Effectiveness Engineering for Combination Products initiative. Date and location to be announced.

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