The new journey from research to industry and regulatory practice

One of the main messages of the Global Regulatory Science Summit held in Brasilia in September was that decision-making about safety assessment is undergoing a major transition. Many new types of heterogeneous scientific data must now be integrated as evidence into assessments. And, as medicine becomes more personalised, increasing amounts of data on individuals must also be managed.

How can we best use this new evidence? When we are operating in new contexts, so different from the traditional study designs of animal experiments or the statistical results on outcomes and safety obtained from large clinical trials, how should we analyse data and respond to results? And when we are also under new time pressures – for example, when data comes in from biomonitoring on an emergent threat, how do we make the best decisions we can, supported by available data, knowledge and computer models? This new world involves new contexts and also requirements for new practices. Although, as Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, quipped, “It may be still awhile before regulators respond to tweets.”

I think that remarks by some of the preeminent speakers at the GRSS may indicate the way forward. Read More