Advancing regulatory science, advancing regulatory practice

Advancing regulatory science, advancing regulatory practice

In an Editorial of Science in 2011, Margaret A. Hamburg, the then Commissioner of the US Food and Drug Administration highlighted that a strong field of regulatory science is required to develop new tools, standards and approaches that efficiently and consistently assess the safety, efficacy and performance of products, and that this field has long been underappreciated and underfunded.1 During...

Advancing a Vision for Regulatory Science Training.

Regulatory science, a complex field which draws on science, law, and policy, is a growing discipline in medical-related applications. Competencies help define both a discipline and the criteria to measure high-quality learning experiences. This paper identifies competencies for regulatory science, how they were developed, and broader recommendations to enhance education and training in this bur...

Advancing FDA's regulatory science through weight of evidence evaluations.

Advancing Science in Europe

Acknowledgments The DEISA Consortium thanks the European Commission for support through contracts FP6-508830 and FP6-031513. The DECI consists of the identifi cation, enabling, deploying and operation of " fl agship " applications in selected areas of science and technology. These leading, ground breaking applications must deal with complex, demanding, innovative simulations that would not be p...

Informatics for Health 2017: Advancing both science and practice.

INTRODUCTION The Informatics for Health congress, 24-26 April 2017, in Manchester, UK, brought together the Medical Informatics Europe (MIE) conference and the Farr Institute International Conference. This special issue of the Journal of Innovation in Health Informatics contains 113 presentation abstracts and 149 poster abstracts from the congress. DISCUSSION The twin programmes of "Big Data"...