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Renaissance Baltimore Harborplace Hotel

Oct 16, 2023 7:30 AM - Oct 17, 2023 6:30 PM

202 E Pratt Street, Baltimore, MD 21202, USA

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 10: The Future of RWD and RWE

Session Chair(s)

Charles  Lee, MBA, MS

Charles Lee, MBA, MS

Executive Regulatory Science Director

AstraZeneca, United States

In the past two days, this conference has reviewed the proliferation of real world data sources and technological advances that have spurred innovative uses of real world data and real world evidence by sponsors in product development and regulators in product evaluations. In this session, we discuss the future trends for RWE. Potential topics may include:

  • The use of RWE/RWD to address clinical post-marketing commitments issued by the US FDA for novel and supplemental NDA/BLA approvals in oncology
  • FDA’s framework for advancing RWE programs. What comes next?
  • The concept of synthetic data, their applications, and challenges to adoption

Learning Objective : At the conclusion of this session, participants should be able to:
  • Recognize trends in clinical post-marketing commitments (PMC) and requirements (PMR) issued by US FDA in oncology and how RWE can be applied
  • Understand FDA’s current framework for advancing RWE and identify areas for further development
  • Describe the concept of synthetic data and assess opportunities for their application

Speaker(s)

Adam  Shiell, PharmD

Regulatory Trends in Oncology Post-Marketing Commitments and Requirements issued by the US Food and Drug Administration: Adam Shiell, PharmD

Global Regulatory Strategist

Flatiron Health, United States

Thomas David Brown, MD, MBA

Beyond the Cures Act: What's Next for FDA's RWE Program: Thomas David Brown, MD, MBA

Chief Medical Officer

Syapse, United States

Lucy  Mosquera, MSc

Synthetic Data for RWD: Lucy Mosquera, MSc

Senior Director, Data Science

Replica Analytics, Canada

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