The EMA published all the presentation materials and the video recording of the Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods. This one-day hybrid Big Data Steering Group (BDSG) workshop brings...
The EMA jointly with the HMA issued a guide on how it can help generate real-world evidence. This document briefly describes how RWE, derived from the analysis of RWD, can be useful in the context...
The US Food and Drug Administration (FDA) this week issued new draft guidance on study design and analysis for non-interventional studies being included as part of a regulatory submission. The draft guidance is one of...
The 21st Century Cures Act, signed into law on 13 December 2016, is intended to accelerate medical product development and bring innovations faster and more efficiently to patients. The FDA has issued a final guidance which provides...
Officials from Health Canada and the pharmaceutical industry addressed plans to develop harmonized guidelines on cell and gene therapies and on the design of pharmacoepidemiological studies that use real-world data (RWD) to assess new medicines...
The US Food and Drug Administration (FDA) has finalized its guidance that outlines the eligibility and submission requirements for applicants interested in submitting new drug applications (NDAs) or biologics license applications (BLAs) for its real-time...
The 4 March 2024, the EMA organised the Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studies. The objective was to provide an overview of the HMA-EMA Catalogues of real-world data sources...
The Data Analysis and Real World Interrogation Network DARWIN EU will continue working towards higher capacity for real-world data (RWD) studies and seeks to add ten new data partners in 2024. Currently, the network operates...
EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues: one for real-world data (RWD) sources and one for RWD studies. The catalogues help medicines regulators, researchers and pharmaceutical companies to...
The EMA issued the 2023 report of the HMA-EMA Big Data Steering Group (BDSG). This report is based on the third BDSG workplan and provides a summary of the key activities and achievements of the...
