Regulatory Science as an Important Principle of Good Consultancy Practices (“GCP”)

by Michael Pfleiderer

Regulatory science is the foundation of regulatory decision-making and is used to assess the quality, safety, and efficacy of human medicinal products throughout their life-span. The domains, covered by regulatory science, are considered to include both basic and applied biomedical sciences, clinical trial methodology and epidemiology, and social sciences. In the report by Michael Pfleiderer, you can read about the importance of regulatory sciences to contribute to the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated products.