#125: Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence
Monday, June 16, 2025 2:15 PM to 3:15 PM · 1 hr. (America/New_York)
207B
03: Data-Tech09: Regulatory
Information
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.
CE
ACPECMERN
Session Level
Intermediate
Featured Topics
Real-World Data (RWD) / Real-World Evidence (RWE)
Learning Objectives
Examine the challenges and value of real-world data (RWD) in regulatory decision-making and acceptance; Discuss strategies for integrating RWD into dossier data to align with decision and evaluation processes for global regulatory acceptance; Identify challenges in standardizing data collection and sharing across industry, regulators, and academia.
Speakers
MB
Mehmet Burcu
Senior Director, EpidemiologyMerck & Co., Inc.
Donna Rivera
Executive Vice President-Clinical Evidence ModernizationCanal Row Advisors
Laura Lasiter
Regulatory Affairs Director- Digital HealthAstrazeneca
Shirley Wang
Associate Professor of MedicineHarvard Medical School
Patrice Verpillat
Head of Real World EvidenceEuropean Medicines Agency