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Renaissance Baltimore Harborplace Hotel

Oct 16, 2023 7:30 AM - Oct 17, 2023 6:30 PM

202 E Pratt Street, Baltimore, MD 21202, USA

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 8: Cross-Industry Consortia Initiatives Addressing RWD Heterogeneity

Session Chair(s)

Brittany  McKelvey, PhD

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


Meredith Nahm Zozus, PhD

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

David  Moeny, MPH, RPh

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

Abi  Seifert, MBA

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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