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Tuesday, June 21 • 2:00pm - 3:00pm
#249: Regulatory-Grade Real-World Evidence: Distilling to Practice

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-569-L04-P ; CME 1.00; RN 1.00

Real-world evidence (RWE) is increasingly used to complement randomized clinical trials (RCT), provide a better understanding of real-world effectiveness, and address information gaps. This session will explore various best practices, tools, and methods used.

Learning Objectives

Describe various levels of real-world evidence (RWE) validity and their relationship to current regulatory RWE guidance; Identify rigorous methodological approaches to maintain evidentiary standards and the impact of underlying data quality in RWE study results; Evaluate future study design using advanced RWE to support medical affairs, market access, and regulatory objectives.

Chair

Dan Riskin, MD, MBA

Speaker

Developing High-Validity Real-World Evidence to Meet Clinical, Regulatory, and Commercial Objectives
Dan Riskin, MD, MBA

FDA Update
John Concato, MD, MPH, MS

Practical Tools to Advance Fit-for-Purpose Use of Real-World Data in Regulatory Decision-Making
Cathy W Critchlow, PhD, MSc

Evaluating Machine Learning Derived Real-World Data to Support Regulatory Decision Making
Irene Nunes, PhD



Speakers
avatar for Dan Riskin

Dan Riskin

Founder and Chief Executive Officer, Verantos, United States
Dan Riskin is the founder and CEO of Verantos, the market leader in high-accuracy real-world evidence (RWE) generation. Recognized across the globe as an expert in healthcare AI, Dr. Riskin has developed products that influence the care of millions of patients annually. His advocacy... Read More →
avatar for Cathy Critchlow

Cathy Critchlow

Vice President, R&D Data Strategy, Amgen, United States
Dr. Critchlow leads R&D Data Strategy, focusing on synergizing cross-functional capabilities in multi-omics, clinical trial and real world data (RWD) to increase the probability of success in bringing innovative medicines to patients. She previously led Amgen’s Center for Observational... Read More →
avatar for John Concato

John Concato

Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). After conducting clinical research studies for more than 25 years as an independent investigator... Read More →
avatar for Irene Nunes

Irene Nunes

Vice President, Head of Regulatory Affairs, Flatiron Health, United States
Irene Nunes is VP, Head of Regulatory Affairs at Flatiron Health, leading strategy and policy professionals focused on advancing RWD/RWE for regulatory decision-making and market access globally by working with pharmaceutical companies, regulatory agencies, HTAs, policy organizations... Read More →
avatar for Dan Riskin

Dan Riskin

Founder and Chief Executive Officer, Verantos, United States
Dan Riskin is the founder and CEO of Verantos, the market leader in high-accuracy real-world evidence (RWE) generation. Recognized across the globe as an expert in healthcare AI, Dr. Riskin has developed products that influence the care of millions of patients annually. His advocacy... Read More →


Tuesday June 21, 2022 2:00pm - 3:00pm CDT
Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Forum |   04: MedAffairs-SciComm, Forum |   09: Regulatory, Forum
  • Level Intermediate
  • Featured Topics RWD-RWE
  • Level Intermediate
  • Feature Topics RWD-RWE
  • Credit Type ACPE, CME, RN
  • Tags Forum