AMSTERDAM and Tucson, Ariz., March 24, 2022 (Reuters) /PRNewswire/ – C-Path Europe will work closely with its US counterpart to promote the development of novel regulatory-approved methods to accelerate medical product development
To support its mission of advancing innovation for health around the world, the Critical Path Institute (C-Path) announced the opening of its EU headquarters in The Netherlands for existing and future charitable activities in Europe.
C-Path is recognized worldwide as a leader in regulatory science. The organization has extensive knowledge and experience when it comes to obtaining regulatory approval for drug development tools (DDTs) or novel methods in collaboration with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japan Drugs and Medical Devices Agency (PMDA). All of the regulatory-approved C-Path tools and methods are freely available to the broader scientific community.
From its headquarters in Amsterdam, the non-profit public health organization aims to expand and complement the activities of C-Path. To accelerate regulatory science globally, it will share expertise, data, risks and costs, and enable public-private partnerships with members from the biopharmaceutical industry, government regulators, academic institutions and patient groups in Europe.
“C-Path is already established in Europe and has a long-standing presence here,” said C-Path Board Member Tomas Salmonson, Ph.D., MS, and former Chair of the EMA’s Committee for Medicinal Products for Human Use (CHMP). We look forward to promoting existing and new collaborations and thus providing productive support for European research programs in the field of regulatory science. In doing so, we are making a contribution to the implementation of the EMA’s ‘Regulatory Science Strategy to 2025’.”
Since its inception in 2005, C-Path has worked to forge relationships and foster collaborations in Europe to facilitate global collaboration. C-Path has since had a significant number of Qualification reports and letters of support from the EMA and has an impressive track record of FDA, EMA and PMDA recognition of DDTs and novel methods. These advances in regulatory recognition have helped address various unmet needs in medical product development and have advanced drug development in multiple areas including tuberculosis, polycystic kidney disease, Alzheimer’s, Parkinson’s and irritable bowel syndrome.
“Advancements in drug development are occurring rapidly internationally, and C-Path’s extensive experience in accelerating drug development and approval processes will support innovation in developing novel approaches that can be recognized by regulatory authorities in many countries,” said C-Path Chief Science Officer Klaus Romero, MD, MS, FCP “Collaborating with European organizations continues to be a key priority for C-Path. We are delighted to have an office in Amsterdam. It will definitely help to increase our collaboration and accelerate the development of treatments for some of the world’s most complex health problems.”
A webinar, C-Path in Europe: Moving Global Regulatory Science Forward, is scheduled for April 20, 2022. Contact us here an.
For more information, see https://c-path.org/c-path-in-europe.
The Critical Path Institute (C-Path) is an independent, non-profit organization founded in 2005 as a public-private partnership. C-Path’s mission is to initiate the development of new approaches to foster innovation in medicine and regulatory science and accelerate the journey to a healthier world. C-Path is a global leader in forming collaborations and has formed numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations and hundreds of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona, C-Path Europe is headquartered in Amsterdam, The Netherlands, and C-Path Ltd. operates out of Dublin, Ireland and has additional employees in several other locations. For more information, see c-path.org.
In the United States, the Critical Path Institute is administered by the Food and Drug Administration ( FDA ) des Department of Health and Human Services ( HHS ) and funded 54.2% by the FDA/HHS for a total of $13,239,950 and 45.8% from non-governmental sources for a total of $11,196,634. The contents are those of the author(s) and do not necessarily represent the official opinion of, or have been endorsed by, the FDA/HHS or the US Government.
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