News from the healthcare data industry
New sources of evidence, such as big data in healthcare, offer opportunities to improve decision-making for better outcomes. However, uncertainties may exist around the quality of the data and the...
01 Aug 2022 NEWS Ian Schofield@ScripIanS ian.schofield@informa.com Executive Summary The EU’s big data steering group has laid out some ambitious proposals for integrating real-world evidence into regulatory decision making, as well...
The scope of RWE’s use in developing and approving new medicines is pitting key healthcare stakeholders against each other. It’s been coming for years, but now it’s starting to bite....
EMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International Coalition of Medicines Regulatory Authorities (ICMRA)....
As more and more biotechs are looking into the potential applications of using real-world evidence in regulatory submissions, the European Medicines Agency is calling for more widespread adoption. EMA endorsed...
Executive Summary The latest meeting of the DARWIN EU advisory board heard about moves to increase the number of RWD sources that can be analyzed and to improve the efficiency...
The major review of European pharmaceutical legislation that will start later in 2022 has brought together two major healthcare players who have, by their own admission, still a lot of...
Executive Summary Neurodegenerative and cardiovascular diseases, along with cancer and early feasibility studies, are among the topics to be addressed by consortia interested in taking part in the EU’s latest...
Executive Summary England’s health technology appraisal institute, NICE, has published its real-world evidence framework.NICE LAUNCHES RWE FRAMEWORK With its newly published real-world evidence (RWE) framework, NICE, England’s health technology appraisal...
Executive Summary A technical workshop is planned for later this year to identify common “use cases” for real-world evidence that are important to the European Medicines Agency, health technology assessment...