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Enabling Science and technology in medicines development – EMAs Regulatory Science Strategy to 2025

Presentation Abstract:  

The European regulatory system for medicines (the ‘EU network’, or EMRN) is a network of all the national medicines regulators (human and veterinary) from EEA member states, the European Medicines Agency (EMA) and the European Commission. This unique system serves a population of over 400 million people.

Amongst other,the EU network is responsible for providing a regulatory environment that supports innovation and the development of new and better medicines to meet human and animal health needs. To do this, they must proactively engage with and foster advances in regulatory science and work closely with all their stakeholders. 

It is our duty to constantly challenge our capacity to regulate:

  • How ready are we to engage with emerging science and technological innovations such as big data, precision medicine, novel manufacturing, novel clinical trials design, and the revolution in synthetic biology?
  • Do we have the necessary skills and competencies, or indeed access to the specific expertise required?
  • Are we generating new guidance or providing sufficient levels of advice to facilitate the utilisation and translation of these innovations?

EMA’s Regulatory Science Strategy to 2025 - A public health aim will be presented. Examples of the transformational research that is having a significant impact on the regulatory science agenda include cell-based therapies, genomics-based diagnostics, drug-device combinations, novel clinical trial design, predictive toxicology, real-world evidence, and ‘big data’ and artificial intelligence.