DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-522-L04-P; CME 1.00; RN 1.00

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 Objectives

Examine the challenges and value of real-world data (RWD) in regulatory decision-making; Discuss the guidance on data quality and feasibility of RWD for real-world evidence (RWE) studies in health authority interactions; Recognize 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.

Chair

Mehmet Burcu, PhD, MS, FISPE

Speaker

Data Quality Framework and EMA Regulatory Perspectives
Patrice Verpillat, DrMed, MD, PhD, MPH

Oncology Quality, Characterization, and Assessment of Real-world Data: US Regulatory Perspectives
Donna Rivera, PharmD, MSc, FISPE

Building Transparency and Reproducibility into the Practice of Real World Evidence Research
Shirley Wang, PhD, MSc, FISPE

Facilitating robust evidence: integrating digital health data into multi-modal datasets
Laura Lasiter, PhD