2021 PRO Consortium Workshop - Migraine: A Tale of Two Paths to PRO-Based Product Labeling скачать в хорошем качестве

2021 PRO Consortium Workshop - Migraine: A Tale of Two Paths to PRO-Based Product Labeling

The C-Path 12th Annual Patient-Reported Outcome Consortium Workshop was held in virtual format April 14-15, 2021. Overview: Discusses the experience of two pharmaceutical firms’ different paths to obtaining FDA-approved PRO-based label claims for novel migraine drugs Moderator: Stephen Joel Coons, PhD - Executive Director, PRO Consortium; Senior Vice President, Clinical Outcome Assessment Program, C-Path Opening Remarks: Billy Dunn, MD – Director, ON, CDER, FDA Presenters: Pooja Desai, PhD – Director, US Health Economics, Therapeutic Area Lead Inflammation, Nephrology and Bone, Amgen Elizabeth (Nicki) Bush, MHS – Senior Advisor and Head, Patient-Focused Outcomes Center of Expertise, Eli Lilly and Company Panelists: Eric Bastings, MD – Acting Director, Division of Neurology I; Deputy Director, ON, CDER, FDA Nick Kozauer, MD – Director, Division of Neurology II, ON, CDER, FDA Elektra Papadopoulos, MD, MPH – Acting Deputy 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