News & Events
May 9, 2017 - May 10, 2017
Advancing CDISC Standards for Biosensors Assessments in Clinical Drug Trials: 2017 Biometric Monitoring Device WorkshopMay 9-10, 2017 Bethesda North Marriott Hotel and Conference Center Bethesda, MD Meeting Overview/Objectives: Review contemporary use cases for mobile biosensor assessments of three domains of function that are impacted by Neurological Disorders (mobility/sleep/cognitive performance). Review & address key regulatory considerations for various Contexts-of-Use. Convene CDISC Standard experts to advance a plan that enables data...
April 26, 2017 - April 27, 2017
Eighth Annual Patient-Reported Outcome Consortium WorkshopApril 26 – 27, 2017 Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814 On April 26-27, 2017 the EIGHTH ANNUAL PATIENT-REPORTED OUTCOME CONSORTIUM WORKSHOP was held in Bethesda, Maryland. The overall Workshop objectives were to: • Provide an update on FDA’s Clinical Outcome Assessment (COA) Qualification Program; • Describe progress within the PRO...
April 25, 2017
Second Annual Workshop On Clinical Outcome Assessments In Cancer Clinical TrialsAssessing Tolerability of Cancer Treatments: Optimizing the Role of Patient-Reported Data April 25, 2017 Hyatt Regency Bethesda 1 Bethesda Metro Center Bethesda, MD 20814 CO-SPONSORED BY: Critical Path Institute U.S. Food and Drug Administration Workshop Agenda 7:30-8:15 am Registration and Continental Breakfast – Regency I and II 8:15-8:30 am Welcome and Opening RemarksPaul G. Kluetz,...
April 5, 2017
INC Necrotizing Enterocolitis (NEC) Workgroup Meeting at UC DavisOn behalf of the NEC Co-Chairs, Mickey Caplan and Jennifer Canvasser, thank you for contributing to the success of the International Neonatal Consortium’s NEC Workgroup meeting at UC – Davis on April 5, 2017. For your information, the meeting slides can be found here. Mickey Caplan’s brief meeting overview follows: Thanks to you all for participating in...
March 27, 2017 - March 29, 2017
Applying Regulatory Science to Neonates: Third Annual Scientific WorkshopMarch 27 – 29, 2017 Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, North Bethesda, Maryland 20852 USA Sponsors: Critical Path Institute and U.S. Food and Drug Administration Agenda – Day 1, March 27, 2017 8:00 am – 4:00 pm (Brookside B) INC Severity Scale for Neonatal Adverse Events Workgroup Meeting 8:00 am – 4:30...