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How to Integrate Real-World Evidence into Regulatory Submissions-PDF

This PDF provides a comprehensive guide on incorporating Real-World Evidence (RWE) into regulatory submissions. It explores key methodologies, regulatory expectations, and strategic approaches for leveraging RWE to support drug approvals and labeling claims. Ideal for regulatory affairs professionals, clinical researchers, and life sciences stakeholders aiming to enhance submission outcomes using real-world data.<br><br>

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How to Integrate Real-World Evidence into Regulatory Submissions-PDF

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  1. How to Integrate Real- World Evidence into Regulatory Submissions Group: pubrica.com Email: sales@pubrica.com

  2. Introduction Real-world evidence (RWE) is gaining traction globally in drug and device development. Regulatory submissions are no longer reliant solely on randomized controlled trials (RCT). Real-world data supports label extensions, post- marketing needs, and rare conditions. sales@pubrica.com +44 161 394 0786 +91 9884350006 pubrica.com Copyright © 2025 pubrica

  3. Understanding RWE and Its Role RWE is clinical evidence on use/risks of a product based on real-world data (RWD). Common RWD : EHRs, billing records, registries, health apps, pharmacy/lab records. Example :EHR diabetes registry used to measure cardiovascular outcomes. sales@pubrica.com +44 161 394 0786 +91 9884350006 pubrica.com Copyright © 2025 pubrica

  4. Regulatory Acceptance of RWE FDA (USA):21st Century Cures Act (2018) — supports approvals and new indications. EMA (EU): DARWIN EU — measures effectiveness and safety using RWE. MHRA (UK): ILAP — encourages early access submissions utilizing RWE. sales@pubrica.com +44 161 394 0786 +91 9884350006 pubrica.com Copyright © 2025 pubrica

  5. Step-by-Step Guide (Purpose + Quality) Determine purpose:label extension, safety data, comparator arm, post-authorization needs. Example:Registry data shows asthma inhaler adherence in children. Evaluate RWD:check completeness, accuracy, timeliness, and representativeness. sales@pubrica.com +44 161 394 0786 +91 9884350006 pubrica.com Copyright © 2025 pubrica

  6. Study Design + Analysis Plan Select design: retrospective cohort, case-control, observational, external control, pragmatic trials. Develop robust analysis: define endpoints, criteria, adjustments (e.g., propensity scores). Pro Tip: Submit pre-specified protocol and Statistical Analysis Plan (SAP). sales@pubrica.com +44 161 394 0786 +91 9884350006 pubrica.com Copyright © 2025 pubrica

  7. Best Practices + Conclusion Collaborate early with statisticians, epidemiologists, and regulatory strategists. Develop RWE templates, align with ICH/regional guidelines, use visuals. RWE is a tool, not a shortcut — done right, it fills trial gaps and speeds access. sales@pubrica.com +44 161 394 0786 +91 9884350006 pubrica.com Copyright © 2025 pubrica

  8. Contact Us UNITED KINGDOM +44 161 394 0786 INDIA +91-9884350006 EMAIL sales@pubrica.com Copyright © 2025 pubrica

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