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Session 8: Cross-Industry Consortia Initiatives Addressing RWD Heterogeneity
Session Chair(s)
Brittany McKelvey, PhD
Director, Regualtory Affairs
Friends of Cancer Research, United States
While the number of studies utilizing RWD has increased significantly, there is a lack of standardized methodologies for capturing and analyzing real-world data (RWD) to generate real-world evidence (RWE). Coordinated efforts across the biopharmaceutical industry, academia, data vendors, and patient advocacy organizations can support robust use of RWD/E to generate lessons learned to promote consistency and standards in the field. This session will discuss cross-industry consortia and initiatives and early findings to advance the use of RWD/E.
Learning Objective : At the conclusion of this session, participants should be able to:- Explain the need for collaborative studies focused on RWD/E methodologies and quality
- List examples of cross-industry RWE-related consortia, opportunities to engage, and lessons learned for future efforts
- Describe how results obtained from these activities promote a consistent approach for the robust use of RWD
Speaker(s)
Early Field Experience From the AnCillary Studies to Evaluate EHR and Claims Real-World Data (ACE-RWD)
Meredith Nahm Zozus, PhD
University of Texas Health Science Center, United States
Professor; Division Chief and Director, Clinical Research Informatics
Harmonizing Guidelines on Post-Approval Observational Safety Studies for Medicines: Background, Status and Future of ICH M14
David Moeny, MPH, RPh
FDA, United States
Acting Deputy Director, Office of Pharmacovigilance and Epidemiology, OSE/CDER
Assuring Audit and Inspection Readiness – Considerations for the Use of RWE/RWD in Regulatory Decision-making – Update from the TransCelerate Real World Data ARC Initiative
Abi Seifert, MBA
Novartis , United States
Global Head Country Development Quality
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