a Comprehensive Inventory (CI) has been developed to assist European academic drug developers in finding support on regulatory affairs. The inventory lists various support services provided by national competent authorities, public actors and private entities by:
* Expertise area (ATMP, Biologicals, biomarkers, chemicals, diagnostics, drug repurposing, drug-device combinations, e/m health, ethical aspects, IVD/ Blood products, legal matters, medical devices, paediatric studies, statistics, societal aspects)
* Support activity (assistance in clinical trial application, pre-grant advice, GCP, GLP, GMP, non clinical, pre-clinical, paediatrics, Phase I, PHase II-III, Phase IV, pre-grant advice, quality)
CSA STARS
STARS – Strengthening Training of Academia in Regulatory Science
STARS aims to analyse the current situation and improve the training of academia in regulatory sciences and thereby further enhance regulatory knowledge. The overall goals of STARS comprise also strengthening academic, regulatory science on national and European level, as well as improving success in regulatory Scientific Advice and Protocol Assistance of academic driven health research.
During the 3 years project period, STARS will
* establish a Comprehensive Inventory of existing support activities for academic researchers, in order to improve success during Scientific Advice and Protocol Assistance procedures;
*expand the establishment of best practice examples for efficient Support Activities / training programmes and by providing specific advice and support for the establishment of tailored activities and addressing the identified gaps;
* establish a Common Strategy to strengthen regulatory sciences and improve the support for successful outcomes from regulatory Scientific Advice, which will be agreed and implemented by the partners of the STARS project.
* explore and monitor the implementation of a pre-grant regulatory scientific advice on the level of participating Member State also, in order to address the identified need to complement, coordinate and harmonise the national and European efforts.