Last March, the World Duchenne Organization in collaboration with Duchenne Data Foundation organized the second Meeting on FAIR Data Sharing for Duchenne. During this meeting, 120 participants from 22 countries discussed how they could drive FAIR data efforts to facilitate research and healthcare. Click here to read the full report In order to improve care…
All ERNs are tasked to set up patient registries that follow the FAIR Principles, as these ‘FAIR registries’ are essential for enabling efficient analysis of data across multiple sources. Existing methods to make clinical trial and registry data (more) machine-readable and FAIR are usually carried out after a research project is conducted and data are…
[PRESS RELEASE] The Critical Path Institute (C-Path), an independent nonprofit organisation, and Pulse Infoframe, a real-world evidence generation, health informatics and insights company, have announced their collaboration to advance technologies and tools to further rare disease research and drug development. Both organisations will support the creation of more streamlined and transparent informed consent processes and…
The European Medicines Agency (EMA) is organising a webinar for small and medium enterprises (SMEs) and academia on the Clinical Trial Regulation (Regulation (EU) No 536/2014) and the Clinical Trials Information System (CTIS). The webinar will take place on November 29, 2021 from 09.00 – 13.15 CET. The webinar is being organised as a training event and will present: an…
EJP RD is co-organising the « Rare Conversations – European Rare Disease Ecosystem: A Collaborative Path Forward » conference in cooperation with Alexion, EURORDIS, EUCOPE, and EuropaBio. The conference is targeted towards representatives of the different communities active in rare diseases: patients, researchers, clinicians, regulators, investors, payers, and industry. The fully online conference will take place on November 9, 2021 from 14.00 – 18.00 CET.…
The European Health Data & Evidence Network (EHDEN) Consortium and the European Patients’ Forum (EPF) have jointly developed a free course to provide non-experts with the knowledge they need to better understand the importance of real world data, how it’s protected, and the vital role they can play in the healthcare ecosystem and health research.…
The EHDEN Consortium announces its 5th Open call targeted towards data custodians of Electronic Health Records, Claims, Hospital and Registry data across Europe, supporting the mapping of their data to the OMOP common data model to accelerate research and healthcare decision-making. The current open call will run from October 13th to November 15th. They welcome all applications, but applications from countries not yet (or minimally) represented…
EURORDIS Rare Diseases Europe is organising its 32nd Round Table of Companies (ERTC) workshop on the theme of « The impact of the EU regulatory network strategy 2020-2025 on the development of orphan medicines » aimed at bringing together participants spread across pharmaceutical, biotech and clinical research organisations (CRO), patient advocates, regulators, HTA bodies, healthcare professionals, researchers…
The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce availability of funds for fiscal years (FY) 2021 – FY 2022 to support innovative and efficient clinical trials for rare diseases and conditions. These studies are intended to provide acceptable data to the FDA that will substantially contribute to…
Primary Care Task Force on « Identifying Key Challenges and Opportunities to Advance IRDiRC Goals with Focus on Primary Care » The IRDiRC Diagnostics Scientific Committee (DSC), Interdisciplinary Scientific Committee (ISC), and Funders Constituent Committee (FCC) have set up a joint Task Force to identify challenges and opportunities in rare diseases research focusing on primary care. This may include diagnosis,…