As technology enables new forms of evidence to be gathered it will be paramount for regulatory professionals to be prepared to engage with patients on which data should be gathered. They will also need to become familiar with new types of data and their analysis, consider possible faster flow of that data to the regulator, and understand the relevance for decision-making by regulators and other stakeholders.
TOPRA’s fourth annual Summit, held in London on 23 May, examined two areas contributing significantly to the evolution of medicines regulation:
- Innovation in regulation – preparing for novel data and approaches that will challenge regulatory decision-making
- Evolution of patient engagement – considering how leaders of regulatory organisations should transform their team’s approach, and why
Hybrid approaches and data sets are being brought to regulators, raising questions on how they should be used in decision-making. Additionally, patient insights are now also routinely incorporated in the research and development of medicines. Regulatory agencies are interested in understanding how to use these insights to support regulatory decision-making, particularly in addressing unmet medical needs.
Several key opinion leaders gave their reflections around the Summit’s themes. This was followed by break-out discussions of two groups, allowing participants the opportunity to develop ideas for how regulatory professionals can enhance their skills to support the different stakeholders to meet the challenges. Attendees also provided suggestions for how to incorporate new science and technologies into future regulatory guidance.
The full Summit briefing is available in the Papers area of TOPRA's website.