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Expert Journal Paper Submission Service in UAE – Pubrica

Streamline your publication journey with Pubricau2019s journal paper submission service tailored for UAE researchers. We handle formatting, document compliance, and complete submissions to reputed academic journals. With in-depth expertise, we ensure your research gets accepted faster with minimal revisions. Trust our end-to-end support for impactful publication outcomes. Choose Pubrica for precise, timely, and professional journal manuscript assistance.<br><br>https://pubrica.com/services/publication-support/

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Expert Journal Paper Submission Service in UAE – Pubrica

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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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