2021 PRO Consortium Workshop - FDA Update скачать в хорошем качестве

2021 PRO Consortium Workshop - FDA Update

The C-Path 12th Annual Patient-Reported Outcome Consortium Workshop was held in virtual format April 14-15, 2021. Overview: Provides an update on FDA’s Clinical Outcome Assessment (COA) Qualification Program and other initiatives Moderator: Michelle Campbell, PhD – Senior Clinical Analyst for Stakeholder Engagement and Clinical Outcomes, Office of Neuroscience (ON), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) Presenters: Robyn Bent, RN, MS – Director, Patient Focused Drug Development Program, CDER, FDA Laura Lee Johnson, PhD – Director, Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, CDER, FDA Elektra Papadopoulos, MD, MPH – Acting Deputy Director, Division of Clinical Outcome Assessment, Office of Drug Evaluation Sciences (ODES), OND, CDER, FDA David S. Reasner, PhD – Division Director, Division of Clinical Outcome Assessment, ODES, OND, CDER, FDA Subscribe to C-Path Now ►►    / criticalpathinstitute   FOLLOW C-PATH: LinkedIn:   / c-path   Facebook:   / cpathinstitute   Twitter: https://twitter.com/CPathInstitute?re ABOUT C-PATH: Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu. #CPath #datasharing #nonprofit #drugdevelopment #PRO