Meetings

The second webinar of the Translating Real-World Data into Real-World Evidence Project, Statistical Analysis and Data Quality, was held on November 8, 2021. 

Materials

Agenda

Meeting Summary (coming soon)

Presentations

Introduction and Project Updates

Veronica Miller, PhD, Forum for Collaborative Research

Case Study, Prograf Approval for Lung Transplants  (see summary notes)

Ryan Jung, PhD, FDA

EHDEN - European Health Data & Evidence Network (An Update)

Nigel Hughes, Janssen Pharmaceuticals/EHDEN

Towards Integration of Targeted Learning in Safety Analysis

Mark van der Laan, PhD, Center for Targeted Learning

Longitudinal Designs in Therapeutic Designs in Rare Disorder

Rima Izem, PhD, Novartis

National Spina Bifida Patient Registry (NSBPR)

Donna Cruz Jones, Patient Advocate

Translating Real-World Data into Real-World Evidence

Pam Vig, PhD, Mirum Pharmaceuticals

Towards Integration of Targeted Learning in Safety Analysis (see summary notes)

Ray Huml, DVM, MS, Syneos Health

The first webinar of the Translating Real-World Data into Real-World Evidence project, U.S. and European Stakeholder Perspectives, was held on July 20, 2021. 

Materials

Agenda

Meeting Summary

Presentations

Introduction and Project Updates

Jessica Weber, Lauren Fisher, Cheri Banks, Veronica Miller, Forum for Collaborative Research

FDA Real-World Evidence Program

John Concato, FDA

EMA Approach to the Use of RWE in Decision-Making

Gianmario Candore, EMA/COMP

Lessons Learned from Use of Real-World Data as External Controls

Bettina Hansen, University of Toronto