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Related Experiment Videos

Regulatory Science in Professional Education.

Hiroshi Akiyama1

  • 1Division of Foods, National Institute of Health Sciences.

Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan
|April 7, 2017
PubMed
Summary

Regulatory science (RS) ensures public safety in pharmaceuticals and food by prioritizing safety over efficacy for food products. This involves comprehensive risk analysis, including assessment, management, and communication, to identify and mitigate potential health hazards.

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Area of Science:

  • Pharmaceutical Sciences
  • Food Safety
  • Environmental Health

Background:

  • Regulatory science (RS) is crucial in pharmaceutical sciences, encompassing pharmaceuticals, food, and living environments.
  • Public acceptance of pharmaceuticals balances efficacy and safety, prioritizing efficacy for disease treatment.
  • Food safety mandates prioritizing safety, as food should be inherently risk-free.

Purpose of the Study:

  • To define the role of regulatory science in ensuring food safety through risk analysis.
  • To explain the components of risk analysis: risk assessment, risk management, and risk communication.
  • To highlight the application of regulatory science in evaluating food quality, efficacy, and safety, as well as environmental chemical safety.

Main Methods:

  • Hazard identification and characterization in food.
  • Scientific risk analysis, encompassing risk assessment, risk management, and risk communication.
  • Development of test methods for evaluating food quality, efficacy, and safety.

Main Results:

  • Food safety is achieved through a structured risk analysis process.
  • Regulatory science supports risk analysis by developing scientific research and testing methodologies.
  • Risk analysis principles are also applied to ensure the safety of environmental chemical substances.

Conclusions:

  • Regulatory science is integral to ensuring public health and safety across pharmaceuticals, food, and environmental sectors.
  • A robust risk analysis framework, including assessment, management, and communication, is essential for food safety.
  • RS provides the scientific foundation for evaluating and managing risks associated with food and environmental chemicals.

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