Learnings initiative webinar for optimal use of big data for regulatory purpose

Regulators need to continuously assess big data in combination with novel methodologies to take decisions on individual products that need to be based on comprehensive, valid and reliable evidence. Use of big data has however introduced new challenges and uncertainties around the quality of an increasing volume of complex data, new analytical approaches, new processes and the need for additional expertise and guidance. The Big Data Task Force Report - Phase 2 emphasised that assessment of big data requires continuous optimisation of current standards and specifications to provide all stakeholders with rules and guidance supporting evidence generation.

Building upon the experience of the submission of real-world evidence for regulatory purpose and the conclusions of previous workshops on data standardisation, metadata and artificial intelligence organised by the Agency, this webinar aims to:

• learn from current experience of using real-world data for regulatory purpose
• discuss important challenges related to optimal use of real-world data, including data relevance, submission processes and training needs
• discuss means to support effective consultation with stakeholders, including industry, the regulatory network, academia, healthcare professionals and patients.

The webinar recommendations will be fed back into internal processes, stakeholder consultations, support for individual product submission and ultimately guidelines for applicants and the regulatory network.

The event will be broadcast.