Regulators are demanding stronger evidence, faster timelines and clearer demonstrations of value, yet traditional randomized trials alone often cannot deliver the speed, scale or real-world relevance required.

The solution? Integrating high-quality real-world evidence (RWE) earlier and more strategically across the product lifecycle to strengthen submissions, reduce risk and accelerate access.

See how industry leaders from Medtronic, Grifols and Johnson & Johnson MedTech are operationalizing real-world data (RWD) to drive regulatory success from early development through post-market impact. 

Key Takeaways:

• Learn how leading organizations are integrating RWE earlier in development.
• Explore what “fit-for-purpose” truly means in regulatory conversations.
• Gain practical strategies for turning RWD into submission-ready evidence.
• See real examples of label expansion, dataset linkage and cost savings.
• Understand how to bridge clinical trials and RWE without duplicating burden.

Don’t miss these insights from ISPOR Europe 2025 that explore how a proactive, lifecycle-based RWE strategy can strengthen regulatory outcomes in the U.S., EU and beyond. 

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