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Development, optimisation and implementation of artificial intelligence methods for real world data analyses in regulatory decision-making and health technology assessment along the product lifecycle

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Development, optimisation and implementation of artificial intelligence methods for real world data analyses in regulatory decision-making and health technology assessment along the product lifecycle Real-world evidence derived from real-world data (RWD) has a promising role to inform regulatory decision-making. Based on highly relevant use cases from regulatory practice and across the product lifecycle Real4Reg develops AI-based data-driven methods and tools for the assessment of medicinal products. Findings will inform training activities on good practice examples and will be implemented in existing and emerging guidelines for both health regulatory authorities and health technology assessment (HTA) bodies across Europe. There is urgent need to enable the use and establish the value of the application of RWD across the spectrum of regulatory use cases. The use of RWD is established in regulatory processes such as safety monitoring,

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recordType

award

status

SIGNED

region

EU

value

6999425

unit

EUR