title: Regulatory Science in Professional Education.
abstract: In the field of pharmaceutical sciences, the subject of regulatory science (RS) includes pharmaceuticals, food, and living environments. For pharmaceuticals, considering the balance between efficacy and safety is a point required for public acceptance, and in that balance, more importance is given to efficacy in curing disease. For food, however, safety is the most important consideration for public acceptance because food should be essentially free of risk. To ensure food safety, first, any hazard that is an agent in food or condition of food with the potential to cause adverse health effects should be identified and characterized. Then the risk that it will affect public health is scientifically analyzed. This process is called risk assessment. Second, risk management should be conducted to reduce a risk that has the potential to affect public health found in a risk assessment. Furthermore, risk communication, which is the interactive exchange of information and opinions concerning risk and risk management among risk assessors, risk managers, consumers, and other interested parties, should be conducted. Food safety is ensured based on risk analysis consisting of the three components of risk assessment, risk management, and risk communication. RS in the field of food safety supports risk analysis, such as scientific research and development of test methods to evaluate food quality, efficacy, and safety. RS is also applied in the field of living environments because the safety of environmental chemical substances is ensured based on risk analysis, similar to that conducted for food.
authors.affiliation: Division of Foods, National Institute of Health Sciences.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Akiyama
mesh_terms: D000818:Animals; D004335:Drug and Narcotic Control; D004512:Education, Pharmacy; D063427:Food Quality; D059022:Food Safety; D064088:Hazard Analysis and Critical Control Points; D006801:Humans; D011634:Public Health; D018570:Risk Assessment; D012308:Risk Management; D012586:Science