The U.S. Food and Drug Administration (FDA) guidance on real-world evidence (RWE) underscores the need for early engagement with the Agency to discuss real-world data (RWD) sources and non-interventional study designs prior to regulatory submission.

Join us for this webinar when we will explore how a robust and multidisciplinary feasibility methodology can de-risk regulatory and scientific strategy for external comparator studies. We will discuss key considerations for conducting feasibility assessment for external comparators utilizing RWD for regulatory submission, and strengthen understanding of these concepts through illustrative case studies.

Key takeaways:

• Unpack why feasibility assessments are needed when designing external comparators
• Highlight the essential processes for conducting feasibility assessments effectively
• Examine opportunities and challenges in conducting feasibility assessments, along with strategic recommendations for successful execution

Speakers:

Leanne Li, MPH, MBA
Sr. Principal, Regulatory Science & Study Innovation, IQVIA

Mayank Raizada, MS
Principal, Regulatory Science & Study Innovation, IQVIA

Julien Heidt, MS
Sr. Consultant, Regulatory Science & Study Innovation, IQVIA

Dony Patel, PhD
Director, Global Database Studies, IQVIA