Ensuring the safety of biological products, drugs, and devices in healthcare is the shared responsibility of regulatory, academic and industry-related stakeholders.
Current safety surveillance systems rely upon analysis of spontaneous, voluntary reports and of administrative claims, electronic medical records, and some post-marketing pharmacovigilance studies. A limited number of surveillance systems have utilized innovative analytical and statistical techniques, including data mining, machine learning, and artificial intelligence, to interrogate real-world data. While these approaches are important and complementary, they fail to harness the full power of cooperation across stakeholders and of global inclusivity. In collaboration with others, the MRCT Center is launching the Proactive Safety Surveillance initiative which aims to improve upon the current safety surveillance systems by creating a global, cooperative approach for more proactive, predictive safety surveillance system(s).
As the official launch to the project, on May 3, 2019, MRCT Center will invite stakeholders from industry, government and academia to participate in an invitation-only small meeting or Visioning Session in order to identify the salient issues, the challenges, the opportunities and to further explore the need for and characteristics of such an approach. The session will be a partnership of best minds with diverse perspectives to enable the evaluation and adaptation of new technologies, methodologies, and insights to better support the determination of the medical importance and validity of safety signals for the global community. While inevitably challenging, we believe exploration of such questions holds the promise of increasing the timely detection, validation, and communication of important safety information.