External comparators (ECs) built from real world data (RWD), and the resulting real world evidence (RWE), are increasingly being applied to support initial regulatory approval and labeling changes for marketed products.

Join us for this webinar where we will discuss recommendations from the FDA draft guidance and success factors for getting ECs right in oncology.

Key Topics:

• Overview and implications of the recent FDA draft guidance on ECs
• Operational and key methodological success factors for developing ECs
• Additional clinical considerations within the indication of oncology

Speaker

Leanne Li, MPH, MBA
Sr. Principal, Real World Strategy and Innovation, U.S. Real World Solutions, IQVIA

Mayank Raizada, MS
Principal, Regulatory Science & Strategy, IQVIA

David Alsadius, MD, PhD
Sr. Medical Director, Medical Strategy Lead for Oncology, IQVIA

Mohsin Shah, MBBS, MSCE
Consultant Epidemiologist, Epidemiology and Drug Safety, U.S. Real World Solutions, IQVIA