Back to Agenda
Session 2: Ensuring Quality and Integrity of Real-World Data: Regulatory Insights
Session Chair(s)
Motiur Rahman, PhD, MPharm, MS
Senior Epidemiologist and Policy Advisor, Real World Evidence Analytics, OMP, CD
FDA, United States
As regulatory use of real-world data (RWD) grows, challenges in data review, inspection, and quality assurance have become increasingly complex. This session will explore the difficulties regulators and industry face in ensuring data integrity, traceability, and compliance with standards like CDISC SDTM. A case study from Nordic registries will illustrate how high-quality RWD supports regulatory-grade pharmacovigilance. Attendees will gain insights into practical solutions and best practices for advancing RWD in regulatory submissions. The panel will also discuss innovations needed to address RWD-specific nuances and enhance global regulatory confidence. Perspectives from both regulators and industry will provide a comprehensive view of current challenges and future opportunities.
Learning Objective : - Outline key challenges in reviewing and inspecting real-world data (RWD) in regulatory submissions within the session timeframe
- Describe characteristics of high-quality Nordic RWD that support regulatory-grade pharmacovigilance by the end of the session
- Explain practical strategies and emerging solutions to improve data integrity, traceability, and regulatory confidence in RWD during the session
Speaker(s)
Review and Inspection of Real-World Data (RWD) in Regulatory Submissions: Challenges and Solutions
Mayur Saxena, PhD
Droice Labs, United States
Chief Executive Officer
Making the Grade: How Data Quality Enables Regulatory-Grade Evidence in Pharmacovigilance
Kirk Geale, PhD, MS
Quantify Research, Sweden
CEO
Assessing Data Reliability in RWD/RWE Studies: Lessons from Regulatory Inspections
Kassa Ayalew, MD, MPH
FDA, United States
Director, DCCE, OSI, Office of Compliance, CDER
Have an account?