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Session 3: RWD Innovations in Late Phase and Postmarket Settings: A Review of Use Cases
Session Chair(s)
Camille Jackson
Director, Regulatory Policy; Legal and Regulatory
Flatiron Health , United States
Real world data can help answer a number of research questions across the drug development lifecycle using innovative study designs and technology. This session will explore recent use cases involving innovations in applying real world data in late phase and postmarket settings. A panel of experts from industry and RWD organizations will share learnings from utilizing registry-based randomized controlled trials (R-RCTs) to improve drug development efficiency, implementing clinical trial linkage to RWD to gain deeper insights to a drug’s benefits and risks, and exploring new ways for studying the medication safety during pregnancy through innovations in post-approval pregnancy safety studies (PA-PSS).
Learning Objective : - Describe the current landscape using recent use cases of RWD innovations in the late phase and postmarket settings
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Describe the best practices for trial linkage and strategies to overcome some of the common challenges in implementation
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Incorporate regulatory considerations into the design of registry-based RCTs and PA-PSS
Speaker(s)
Utilize Registry-based RCT to Improve Drug Development Efficiency: DAPA-MI as a Case Study
Jingyu (Julia) Luan, PhD
AstraZeneca, United States
Executive Regulatory Science Director, BioPharmaceuticals R&D
Implementing Clinical Trial Linkage to Real-World Data (RWD)
Mehdi Najafzadeh, PhD, MA, MS
Medidata AI, United States
Senior Director
Post-Approval Pregnancy Safety Study (PA-PSS) Innovations: New Ways for Studying the Safety of Medications During Pregnancy
Elsie Grace, PhD, MS
Eli Lilly and Company, United States
Senior Director, Global Patient Safety, Pharmacoepidemiology
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