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Thursday, June 20 • 8:00am - 9:00am
#401: Harnessing Real-World Data to Generate Real-World Evidence for Regulatory Grade Safety Studies

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-677-L04-P; CME 1.00; RN 1.00

Session will focus on considerations with successful as well as unsuccessful use cases for generating regulatory grade safety studies using secondary data under new FDA Guidance.

Learning Objectives

Describe considerations when using secondary data to generate real-world evidence for regulatory-grade post-marketing studies; Describe key elements to consider when implementing feasibility assessment to identify real-world data sources.

Chair

Alicia Gilsenan, PhD, MS, RPh, FISPE

Speaker

FDA Update
Marie Bradley, PhD, MPH, MPharm

Value of Real-World Data/Real-World Evidence to Assess Potential Safety Signal: Use Case- Ophthalmology
Angelika Manthripragada, PhD, MPH


Speakers
avatar for Alicia Gilsenan

Alicia Gilsenan

Vice President, Epidemiology, RTI Health Solutions, United States
Alicia Gilsenan, PhD, is Vice President, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI in 1997, she... Read More →
MB

Marie Bradley

Senior Advisor Real-World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Marie Bradley is a Senior Advisor on the Real-World Evidence Analytics team in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA. Her responsibilities related to real-world evidence (RWE) include serving as technical lead for externally conducted... Read More →
AM

Angelika Manthripragada

Director, Pharmacoepidemiology, Global Patient Safety, Regeneron, United States
Angelika Manthripragada is a Director in the Pharmacoepidemiology group in Global Patient Safety at Regeneron, where she leads the epidemiological strategy and support in the areas of Neurology/Pain and Ophthalmology. Prior to joining Regeneron, she worked in the observational research... Read More →

Thursday June 20, 2024 8:00am - 9:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session