by adminBenzi | Aug 9, 2024 | News
The European Network of Research Ethics Committees (EUREC) has issued a position paper addressing the ethical considerations surrounding the compensation of research participants. This important document, adopted in June 2024, outlines the principles and guidelines to ensure fair and ethical compensation practices in health-related research across Europe. More in detail, EUREC categorises compensation into four types: 1. Reimbursement for direct costs related to... 
by adminBenzi | Aug 7, 2024 | News
On July 19, the kick-off meeting of the OrphaDev4Kids (OD4K) project was held in Bari, Italy. The OD4K is a 3-year project - coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche (Italy) and involving 6 European Institutions - aiming to create an ecosystem that facilitates the bringing together of skills, knowledge, research ideas and financial resources, maximizing effectiveness and efficiency in developing innovative solutions for children with... 
by adminBenzi | Jul 31, 2024 | News
The European Commission has released new guidance, namely “Clinical evaluation of orphan medical devices”, aimed at facilitating the clinical evaluation of orphan medical devices. Orphan devices are designed to treat rare diseases affecting no more than 12,000 individuals annually within the EU. These devices often address unmet medical needs where few diagnostic or therapeutic options exist. Key highlights of this guidance are: • Establish criteria for orphan... 
by adminBenzi | Jul 23, 2024 | News
On 3 May 2024, the European Medicines Agency (EMA) has issued a "Reflection Paper on Use of Real-World Data in Non-Interventional Studies to Generate Real-World Evidence". It explores opportunities to harmonise the use of real-world data (RWD) to generate real-world evidence (RWE) in non-interventional studies. This initiative aims to improve the integration of RWE in regulatory decision-making processes, thereby enhancing the evaluation of the benefits and risks... 
by adminBenzi | Jul 16, 2024 | News
The European Paediatric Translational Research Infrastructure (EPTRI) will hold its General Assembly and Scientific Meeting on 18 and 19 July in Bari, Italy. This key event will bring together researchers, industry representatives, healthcare professionals and patient advocacy groups to discuss the latest advances in paediatric research and how EPTRI can provide support through its specialised services. The European Paediatric Translational Research Infrastructure... 
by adminBenzi | Jul 4, 2024 | News
Between 4 and 6 June 2024, 140 people from c4c beneficiaries met in Bergen, Norway, for the c4c General Assembly. This meeting was a great opportunity for colleagues to meet again and collaborate further for the benefit of the c4c network. The aim of this meeting was to provide an update on progress to date and to discuss plans for the future of c4c, particularly now that the conect4children Stichting (c4c-S) has been established to support the c4c network and... 
