November 16, 2017 FDA CDER Regulatory Science: The Importance of Partnership and Consortia Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research within the United States Food and Drug Administration,
February 28, 2017 Bring Your Own Device (BYOD) This webinar provides an overview of scientific, logistical, and regulatory considerations when using a BYOD approach to collect p
February 28, 2017 Considerations for Requiring Subjects to Respond to PRO Instruments Collected Electronically This webinar provides an overview of specific considerations related to allowing subjects to opt out of responding to individual i
February 24, 2017 Biomarker Qualification: Collaboration, Strategy, and Implementation Biomarker Qualification: Collaboration, Strategy, and Implementation Webinar February 24th, 2017 Presenter: John Michael Sauer, Ph
January 31, 2017 Highlights from the 02 August CDISC Strategy Session The CDISC Strategy Session highlight video includes an interview with Cheryl Fitzer-Attas (CHDI Foundation) discussing the importa
May 18, 2016 PRO Consortium Webinar: Methods for Determining Clinically Meaningful Change This webinar explores methodological approaches for determining whether changes observed in patient-reported outcome measures and
December 3, 2015 Ensuring Equivalence of Electronic and Paper Administration of Patient-Reported Outcome Measures This webinar provides an overview of scientific and regulatory considerations when migrating paper-based patient-reported outcome
September 2, 2015 Evidentiary Considerations for Integration of Biomarkers in Drug Development Symposium Evidentiary Considerations for Integration of Biomarkers in Drug Development Symposium On August 21st, the University of Maryland&
June 5, 2015 Migrating a PRO Instrument This webinar provides a detailed description of the process for conducting paper to ePRO migration, mode-specific migrations, usab
April 13, 2015 Intro to ePRO – Part II This webinar provides an overview of current ePRO data collection modes, the mode selection process, key considerations for select