News & Events
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June 6, 2017
Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium
This webinar provides a recommended framework for the selection and evaluation of wearable devices and their measurements for use in regulatory trials to support labeling claims. The webinar will also address the essential properties of fit-for-purpose wearables and the activities required to establish clinical endpoints derived from data collected with wearable devices. Presenters: Bill Byrom,...... -
June 6, 2017 - June 7, 2017
Drug-Induced Liver Injury (DILI) Conference XVII
Asymmetry of Drug Safety and Efficacy in Clinical Trials with DILI- Toward Quantitative Estimate of Net Benefit to Patients June 6, 2017 – June 7, 2017 College Park Marriott Hotel and Conference Center Paul Watkins, Mark Avigan, John-Michael Sauer, Arie Regev, Gyongyi Szabo, John Senior Drug-induced liver injury (DILI) is a major problem for drug...... -
June 4, 2017 - June 8, 2017
Critical Path for Parkinson’s Consortium Posters from the 21st International Congress of Parkinson’s Disease and Movement Disorders
C-Path’s Critical Path for Parkinson’s Consortium (CPP) presented three posters at the 21st International Congress of Parkinson’s Disease and Movement Disorders, held June 4-8 in Vancouver, BC, Canada. The posters highlight the consortium’s work in regulatory science and drug development tools for Parkinson’s. The first poster details global regulatory support in using dopamine transporter neuroimaging...... -
May 9, 2017 - May 10, 2017
Advancing CDISC Standards for Biosensors Assessments in Clinical Drug Trials: 2017 Biometric Monitoring Device Workshop
May 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 Workshop
April 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......