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EU Drafts Recommendations On Identifying Suitable RWD Sources For Studies

 
• By Vibha Sharma

EU regulators have developed a draft good practice guide explaining how stakeholders can make use of the Metadata Catalog of RWD Sources, which is expected to be released in late 2023, to identify appropriate sources for specific research questions.

Businessman searching for big data
Identification of appropriate RWD sources is becoming increasingly important for regulatory decision making • Source: Shutterstock

Regulators in the EU have issued draft recommendations explaining how drug companies and other stakeholders can identify suitable real-world data sources for studies, and what metadata elements they should consider for this purpose.

The recommendations are listed in a draft good practice guide jointly issued by the European Medicines Agency and the...

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