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- - - C-Path is a pioneer in building and managing successful global, cross-sector consortia. The model through which C-Path’s consortia operate was constructed to overcome challenges in collaborative science, providing a framework for fostering collaboration and shattering existing barriers to data-sharing in clinical trials.
    - Critical Path Institute (C-Path) serves as a neutral third party to enable multiple stakeholders across the spectrum of medical product development to work together in a pre-competitive consortium model in order to drive innovative tools and methods which help to de-risk decision making in the development and regulatory review process.
    - C-Path’s staff possess a wide range of scientific, medical, regulatory, technical, and business expertise, and have extensive experience in the academic, government, pharmaceutical, and information technology sectors. Scientific areas of expertise include chemistry, drug development, genetics, microbiology, neuroscience, pharmacology, pharmacometrics and toxicology.
    - Soon, C-Path’s commitment to Europe and European organizations will be solidified, as the plan for a C-Path subsidiary in Ireland evolves. As its parent organization does in the U.S., Critical Path Institute (Ireland) will form consortia of scientists and clinicians from the biopharmaceutical industry, governmental regulatory agencies, academic institutions, and patient groups.
    - The combined expertise of the Board of Directors members and C-Path leadership covers the areas of food and drug law and legislation and regulation, international finance, capital markets, business operations in the pharmaceutical industry, biotech and biomedical communities, and fostering relationships between academia and industry.
    - Critical Path Institute is an equal opportunity employer and participates in the federal E-Verify program.
    - Critical Path Institute, or C-Path, is a nonprofit organization that brings together biopharmaceutical firms, universities, patient groups, and regulatory agencies from around the world to improve public health. Together, these stakeholders work to identify or create tools that can accelerate the drug development and regulatory review process.
C-Path in EU
- - - In 2004, FDA and EMA laid the groundwork for joint-agency biomarker reviews when they developed a framework called the Voluntary Exploratory Data Submission review process, which allowed public-private partnerships (PPPs) such as C-Path to submit a single biomarker data application to both regulatory agencies, and then to meet jointly with scientists from both agencies to discuss it in detail and to address additional scientific questions posed by the regulators.
    - In June 2011, C-Path and IMI signed an MoU indicating the intent of the two organizations to find opportunities to leverage one another’s work to accelerate progress and prevent duplication of efforts. The collaboration fosters increased information sharing between each organization’s programs, facilitating knowledge exchange and scientific consensus for research and testing methods.
    - Forging relationships with European entities for more than 10 years.
    - Shortly after its founding in 2005, Critical Path Institute began forging relationships with European entities. In 2007, C-Path’s Predictive Safety Testing Consortium (PSTC), which counted among its members European pharmaceutical company Novartis AG, was the first collaboration to use the Voluntary Exploratory Data Submission review process, which allowed them to submit qualification plans for seven kidney safety biomarkers to FDA and EMA simultaneously
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Category: INC

EMA’s Applying Regulatory Science to Neonates Workshop

Posted on July 2, 2015 | by Mariana | Leave a Comment on EMA’s Applying Regulatory Science to Neonates Workshop

Posted in INC, Videos | Tagged Neonatal/Pediatric, Regulatory/EMA/FDA/PMDA

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