Regulatory science and practice

The Global Summit on Regulatory Science

Advancing reproducible regulatory science and practice

New methods from biology, chemistry and computer science are rapidly changing our approach to safety assessment. To translate these emerging technologies into real-world applications that will make our food and drugs as safe as possible, regulatory decision-makers need these emerging methods to settle down into reliable best practices supported by standards.

Summit in Brasilia

On 18-20 September, the world’s scientists from government, industry and academic-research communities will gather in Brasilia for The Global Summit on Regulatory Science (GSRS) to assess how these emerging technologies can best be used to address regulatory-research questions. In surveying the global regulatory landscape, the conference will seek common issues, in particular, those concerning food and drug safety.

One of the issues to be addressed is the enormous impact that economics, data science and digital healthcare are all having on clinical trials and medicine. How do we organize associated protocols and select and validate the best methods? How do we shepherd all this data and its analysis into a regulatory framework? What is the community funnel towards consensus and convergence in best practice?

Reproducibility

Reproducibility is another key issue. Data science and computational modelling are growing in scientific importance, offering new ways to contribute evidence to emerging regulatory frameworks. Among the many examples are the use of validated predictive models; integrated testing where in silico and in vitro data are combined in a weight of evidence; results generated from complex computer simulations; analysis of an increasing amount of genomics data; and meta analysis across heterogenous data and multiple studies. Evidence from such methods can be used to support decision-making on efficacy, safety and outcomes.

However, important questions remain. What are the best in silico practices for regulatory acceptance and the use of such data? How do we implement such desirable principles as transparency, trust, reliability, robustness, interoperability, harmonization, completeness and confidence into our in silico solutions? And, finally, what is the meaning and importance of in silico reproducibility and what is the framework we need to achieve it?

Given the top-level scientists attending GSRS, we have every reason to hope that some, if not all, of these questions will begin to be answered.

 

Dr Barry Hardy is a Managing Director (CEO) at Douglas Connect

 

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