Session Details

Quality & Operations Track Session 8 - Real World Evidence and Applications in Product Development
Sunday, September 15, 2019 10:45 AM - 12:15 PM 
Ballroom B
The session will have speakers from the FDA/CBER/OTAT, industry and other stake holder groups to address:
•      What is the value of real world evidence (RWE) and how is used by each stake holder: regulator, product developer (industry), etc.
•      What are the current challenges to apply RWE in views of regulators, payers, developers;
•      To address the challenges, what can be done, where to start, and can use stake holder collaborations.


Jiwen Zhang, PhD, PassageBio, USA

Real World Evidence: A Regulatory Perspective
Adnan Jaigirdar, MD, FACS, U.S. FDA, USA
Learning objectives:
•      Assess the role/value of real world evidence (RWE) in regulatory evaluation.
•      What are the current challenges to evaluate RWE in regulatory assessments.
•      What strategies are being undertaken to address these challenges, how to proceed forward

Trends and Challenges in Real-world Evidence Generation
Leanne Larson, MHA, PARAXEL, USA
Learning objectives:
•      Explore trends in applying real-world evidence in stakeholder decision-making
•      Understand current real-world study approaches
•      Understand challenges in implementing RWE studies today

Real World Evidence Generation: Motivations, Challenges and Solutions for Industry and Academia
John Booth, PhD, CTI Clinical Trial & Consulting Services, USA
Learning objectives:
- Discuss the utility of real-world evidence.
- Discuss and compare the motivations and challenges of real-world evidence in Industry and Academia.
- Discuss solutions that can result in synergy between Industry and Academia.

Jiwen Zhang PhD

Adnan Jaigirdar MD, FACS

Leanne Larson
CVP, WW Head of Real-world Evidence
Parexel International