Since the electronic system referred to in IVDR Article 69 (Eudamed and its module for clinical investigations and performance studies) is not yet available and fully functional from the date of application of the IVDR,...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies....
This guidance document is intended to support sponsors in developing their Investigator’s Brochure (IB) by describing in greater detail what type of information is expected in the respective IB sections, in order to preempt questions...
Meeting of the National Competent Authorities on Pricing and Reimbursement and Public Healthcare Payers (NCAPR) held in Brussels on Friday 19 April 2024. Read the news published by the European Commission on 19 April 2024.
The rapid alert platforms for blood (RAB) and for tissues and cells (RATC) give Member States’ competent authorities the possibility to create and launch alerts to each other and/or to request information in case of...
“For up to 36 million people across the EU today, living with a rare disease is a daily reality. Most of them have no cure, and this causes fear and frustration. At national level, resources...
HaDEA has published the call for tenders HADEA/2024/OP/0002 – Programme of Continuous Learning within a European Health Union Professional Network. This call aims to provide a unique fellowship programme focused on continuous professional development for European...
This EUHPP Live webinar was organised by HaDEA to present the procedure to apply for operating grants, under the newly launched call for proposals for a Framework Partnership Agreement for operating grants. Read the news announcement...
The Institute for Interdisciplinary Innovation in healthcare is organizing a symposium on “Gene therapy coming of age”, taking place on 28 March, 2024 in Brussels, Belgium. The symposium will include sessions on recent research and...
Members of the task force from all over the world came together and discussed methodologies and strategies to advance functional analysis for rare diseases. Read the news announcement published by IRDiRC – International Rare Diseases Research...
