22/08/2024 - General information
He has been part of the scientific committee responsible for drafting the document, which was developed to guide regulators on the use of this type of data.
The Council for International Organizations of Medical Sciences, an entity created by the World Health Organization and UNESCO to help advance public health through guidance on research and health policies, has published the report Real-world data and real-world evidence in regulatory decision', in which Dr. Miguel Ángel Mayer, from the Management Control department of Hospital del Mar and its research institute, has participated.
The report aims to provide a universal consensus document that can be used to facilitate the harmonization of regulatory standards and definitions, articulate the requirements to support the determination of drug efficacy, and help develop a set of ethical guidelines for real-world data (RWD) and real-world evidence (RWE) by expanding the use of RWD/RWE for decision-making throughout the entire lifecycle of medical products.
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