EMA is initiating the establishment of the Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®). The role of the Coordination Centre is to develop and manage a network of real-world healthcare data sources across the EU and to conduct scientific studies requested by medicines regulators and, at a later stage, requested by other stakeholders.
The vision of DARWIN EU® is to give real-world evidence, for example on diseases, patient populations, and the use, safety and effectiveness of medicines, including vaccines, throughout the lifecycle of a medicinal product.
DARWIN EU® will provide an invaluable resource to prepare for and respond to future healthcare crises and pandemics. For example, the availability of timely and reliable real-world evidence can lead to innovative medicines becoming more quickly available to patients. Better evidence also supports more informed regulatory decision-making on the safe and effective use by patients of medicines on the market.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
No comments:
Post a Comment
Pharmaceutical Microbiology Resources