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Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence
Session Chair(s)
Mehmet Burcu, PhD, MS, FISPE
Senior Director, Epidemiology
Merck & Co., Inc., United States
This session will discuss regulatory guidance and frameworks on data quality and feasibility assessments of RWD sources to support RWE study proposals for health authority and HTA engagements. It will include information about how to leverage diverse sources of targeted RWD to support and improve the evolution of new therapies and indications for product safety, outcomes, reduction in label use, and help HC professionals and industry to create a knowledge base for use of RWD.
Learning Objective : Examine the challenges and value of real-world data (RWD) in regulatory decision-making; review guidance on data quality and feasibility of RWD for real-world evidence (RWE) studies in health authority interactions; explore strategies to integrate RWD into dossier data for regulatory alignment; identify challenges in standardizing data collection and sharing across industry, regulators, and academia for global acceptance.
Speaker(s)
Oncology Quality, Characterization, and Assessment of Real-world Data: US Regulatory Perspectives
Representative Invited
FDA, United States
Data Quality Framework and EMA Regulatory Perspectives
Representative Invited
European Medicines Agency, Netherlands
Building Transparency and Reproducibility into the Practice of Real World Evidence Research
Shirley Wang, PhD, MSc, FISPE
Harvard Medical School, United States
Associate Professor of Medicine
Facilitating robust evidence: integrating digital health data into multi-modal datasets
Laura Lasiter, PhD
Astrazeneca, United States
Regulatory Affairs Director- Digital Health
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