News & Events

This event brought together leaders in regulatory science. Its goal was to stimulate discussion across all stakeholders and to critically consider lessons learned and recommendations from the STARS project that address regulatory support and the regulatory readiness of academia. Presentations now available!

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The Pilot gave a first insight into essential information and knowledge to develop especially innovative medicinal products alongside the requirements to bring high quality, safe and efficacious products to the European market. The Pilot is now closed.

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The 2nd European Stakeholder Workshop of STARS was a virtual event on 17-18 November 2021. Under the headline "Towards a Common Strategy to Empower Academia in Regulatory Awareness and Knowledge", the workshop followed up on the discussions on how to improve strategies for the regulatory support to academia, and bridge the translational gap of academic-driven health research.

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With Pilot II we aimed to improve the regulatory knowledge of academic health researchers and to enhance regulatory scientific advice.

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The STARS consortium organised in February 2021 a 4-day online training for academia covering topics on basic regulatory knowledge and specific regulatory requirements.

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'Strengthening regulatory science in academia: STARS – an EU initiative to bridge the translational gap' is the title of a new publication currently available in a pre-print version. It outlines what regulatory-related barriers hamper the translational development of novel products or new treatment paradigms initiated in academia, and proposes key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities.

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The 1st European Stakeholder Workshop of STARS was conducted virtually due to the ongoing Covid-19 pandemic on  3-4 November 2020. In total, 100 participants attended the online workshop, representing academic researcher, clinical centers, clinical research networks, funding bodies, regulators from national competent authorities, patient representatives, and industry representatives.

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The STARS consortium met after a very busy first year from 27-28 January 2020 in Lisbon. The meeting was hosted by INFARMED and organised by our Portuguese colleagues Helena Baião, Helena Beaumont and Margarida Menezes Ferreira, who were supported by Vanda Valente at INFARMED and Petra Schumann from the DLR.

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