FDA ADEPT 10: Innovative Strategies for Neonatal & Rare Disease Clinical Trials (Part 2) (Feb 2026) скачать в хорошем качестве

FDA ADEPT 10: Innovative Strategies for Neonatal & Rare Disease Clinical Trials (Part 2) (Feb 2026)

SUBSCRIBE to ⁨@FDALearningCache⁩ to see more videos. Details and supporting materials: https://fdalearn.com/course/fda-adept... Panel Discussion: Leveraging Networks/Consortia/Centers of Excellence to Optimize Harmonization and Operational Feasibility of Neonatal/Rare Disease Clinical Trials Moderator: Shannon Hamrick, MD OPT/OCMO/OC, FDA Panelists: Rachel G. Greenberg, MD, MB, MHS PTN, DCRI Augusto Santos Schmidt MD, PhD Neonatal Research Network (NRN), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) Klaus Romero, MD, MS, FCP C-Path Debra Regier, MD, PhD RareCap Levine Children's Hospital, Advocate Health Ralph Bax, MD, MA Paediatric Medicines Office, Scientific Evidence Generation Department, Human Division, European Medicines Agency (EMA) Sarah Zaidi, MD OPT/OCMO/OC, FDA About: This February 5-6, 2026 workshop was presented by The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI). The aim of the public workshop was to discuss common challenges in neonatal and rare disease product development and identify opportunities to leverage rare disease product development frameworks in the neonatal product development space.