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Critical Path for Parkinson’s Consortium achieves regulatory support in Europe for use of imaging biomarker in Parkinson’s disease clinical trials
Oct 10, 2016 Critical Path for Parkinson’s Consortium achieves regulatory support in Europe for use of imaging biomarker in Parkinson’s disease clinical trials London and Tucson, Ariz., October 10, 2016 — The Critical Path Institute (C-Path), in partnership with Parkinson’s UK, announced today that the European Medicines Agency (EMA) has issued a […]
Critical Path for Parkinson’s Consortium achieves regulatory support in Europe for use of imaging biomarker in Parkinson’s disease clinical trials
Oct 10, 2016 Critical Path for Parkinson’s Consortium achieves regulatory support in Europe for use of imaging biomarker in Parkinson’s disease clinical trials London and Tucson, Ariz., October 10, 2016 — The Critical Path Institute (C-Path), in partnership with Parkinson’s UK, announced today that the European Medicines Agency (EMA) has issued a […]
The Michael J. Fox Foundation for Parkinson’s Research Joins Multinational Critical Path for Parkinson’s Consortium
May 19, 2016 The Michael J. Fox Foundation for Parkinson’s Research Joins Multinational Critical Path for Parkinson’s Consortium Consortium, led by Parkinson’s UK and the Critical Path Institute, aggregates and analyzes study data to develop a model for quantitative characterization of Parkinson’s progression This asset would enrich the design of trials for novel […]
Applying Regulatory Science to Neonates: Second Annual Scientific Workshop at European Medicines Agency (EMA)
Date: September 12-13, 2016 Location: European Medicines Agency, Canary Wharf, London Sponsors: Critical Path Institute and European Medicines Agency The International Neonatal Consortium (INC) organized a two day workshop at the European Medicines Agency (EMA) on September 12-13, 2016. Focused on applying regulatory science to neonates, INC members explored approaches that family and neonatal nursing […]
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C-Path Successes
- >>First preclinical safety biomarkers (7) qualified by the FDA, EMA and PMDA
- >>First imaging biomarker for trial enrichment qualified by the EMA
- >>FDA and EMA reach landmark decisions on C-Path’s Simulation Tool for Alzheimer’s disease
- >>C-Path’s Alzheimer’s Disease Simulator Featured in the Wall Street Journal
- >>C-Path and CDISC partnership delivers therapeutic area standards
- >>FDA and EMA issue first-of-their-kind Letters of Support for two Kidney Biomarkers
- >>EMA Qualifies ‘Hollow Fiber System’ For Anti-Tuberculosis Drug Development
- >>Regulatory Support For Autosomal Dominant Polycystic Kidney Disease Biomarker
- >>C-Path’s PKDOC Secures FDA Qualification for Enrichment Biomarker in ADPKD
- >>C-Path’s PKDOC Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD