Let's Get Real Webinar Series Resources

Supplemental Webinar Series materials are linked below for your reference. We will continue to add related links as the conversation continues! 

Recorded sessions are available for your viewing

Session 1: Beyond the Tower of Babel: FDA Leadership on Data Standards - Sept. 8, 2020

Session 1 Slide Deck

Government Resources:

Framework for FDA’s Real-World Evidence Program

FDA’s Technology Modernization Action Plan

https://www.fda.gov/about-fda/reports/fdas-technology-modernization-action-plan

https://www.fda.gov/media/130883/download

Other Resources:

Registries for orphan drugs: generating evidence or marketing tools?

Harnessing the Power of Real-World Evidence (RWE): A Checklist to Ensure Regulatory-GradeData Quality

Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series

Use of real‐world evidence in regulatory decisions for rare diseases in the United States—Current status and future directions

 

Session 2: Let's Stop Reinventing the Wheel: Scaling Best Practices for Patient Registries - Sept. 15, 2020

Session 2 Slide Deck

Regulatory strategies for rare diseases under current global regulatory statuses: a discussion with stakeholders

Standard Data Structures in Rare Diseases: CDISC User Guide for Duchenne Muscular Dystrophy and Huntington's Disease

Discussion Paper: Use of patient disease registries for regulatory purposes - methodological and operational considerations 

 

Session 3: Let's Get Real (World Evidence): Applications from the Oncology Community- Sept. 22, 2020

FDA-AACR Real-World Evidence Workshop

Real-world Data for Clinical Evidence Generation in Oncology

Real-world outcomes and management strategies for venetoclax-treated chronic lymphocytic leukemia patients in the United States

 

Session 4: From Brooklyn to Beijing: Global Rare Disease Registries as Global Learning Platforms - Sept. 29, 2020

COVID-19 Evidence Accelerator