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.
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
Meet your clinical, economic, and regulatory needs throughout a product's lifecycle using U.S. real world solutions.