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#638: Real World Evidence Throughout the Product Life Cycle: Case Studies and Real-Life Examples
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
116
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-628-L04-P; CME 1.00; RN 1.00

Use of Real-World Evidence (RWE) in regulatory assessments has increased in recent years with use cases spanning across the development, initial authorisation and post-marketing monitoring of medicines. Examples across lifecycle and therapeutic areas will be discussed.

Learning Objectives

Discuss the use of RWE to support regulatory decisions; Identify use cases based on regulatory assessment, stage of lifecycle and therapeutic area; Examine real-world examples of RWE use to identify effective practices and apply insights to future evidence-generation strategies.

Chair

Denise Umuhire, MBA, MSC

Speaker

Panelist
Patricia Furlong, BSN

Panelist
Rohini Hernandez, PHD, MPH

Panelist
Motiur Rahman, PHD, MPHARM, MS


Speakers
avatar for Patricia Furlong

Patricia Furlong

Founding President and Chief Executive Officer, Parent Project Muscular Dystrophy, United States
Pat Furlong is the Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest nonprofit organization in the United States solely focused on Duchenne muscular dystrophy (Duchenne). Their mission is to end Duchenne. They accelerate research, raise their voices... Read More →
avatar for Rohini Hernandez

Rohini Hernandez

Director, Center for Observational Research, Amgen, United States
Rohini Hernandez, PhD, MPH, is a Director of Observational Research in the Center for Observational Research at Amgen. She leads a Pharmacovigilance Epidemiology team focused on leveraging real world data to support benefit/risk assessments globally and across therapeutic areas. Prior... Read More →
avatar for Motiur Rahman

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →
DU

Denise Umuhire

Pharmacoepidemiologist and Real-World Evidence Specialist, European Medicines Agency, Netherlands
I am a pharmacoepidemiologist & RWE specialist within the Data Analytics and Method Taskforce at the Europea Medicine Agency (EMA). I am part of the RWE workstream that provides support on RWE related matters to different evaluation committees, delivering rapid analyses of RWD to... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Session

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