HM6: Real-world evidence and the use of big data for regulatory decision making; DARWIN EU


The session brought together perspectives, from both regulators and the pharmaceutical industry, on the potential that real-world evidence (RWE) can bring to the acknowledgement of the value of medicines post-marketing authorisation.

It is well recognised that as science advances and brings new treatments online, regulatory science must also evolve to make proper and rigorous assessments. Defining what is the right data to be generated, and enabling its use, by recognising its value is increasingly affecting the regulatory science agenda across the world. Eventually, such data can be used to support regulatory applications, leading to better decisions that could allow enhanced access from patients.

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