• 대한예방의학회:학술대회논문집
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• 1994.02a
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• pp.23-56
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• 1994

Recent criticisms of the conduct and use of risk assessment by regulatory agencies have led to a wide range of proposed remedies, including changes in regulatory statutes and the development of new methods for assessing risk. The mandate to this Committee was more limited. Our objective was to examine whether alterations in institutional arrangements or procedures, particularly the organizational separation of risk assessment from regulatory decision-making and the use of uniform guidelines for inferring risk from available scientific information, can improve federal risk assessment activities. Before undertaking to determine whether organizational and procedural reforms could improve the performance and use of risk assessment in the federal government, the Committee examined the state of risk assessment and the regulatory environment in which it is performed. In this chapter, we define risk assessment and differentiate it from other elements in the regulatory process, analyze the types of judgments made in risk assessment, and examine its current government context. Because one chronic health hazard, cancer, was highlighted in the Committee's congressional mandate and has dominated public concern about public health risks in recent years, most of our report focuses on it. Furthermore, because activities in four agencies--the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and the Consumer Product Safety Commission (CPSC)--have given rise to many of the proposals for changes in risk assessment practices, our review focuses on these four agencies. The conclusions of this report, although directed primarily at risk assessment of potential carcinogens as performed by these four agencies, may be applicable to other federal programs to reduce health risks.

• Communications for Statistical Applications and Methods
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• v.25 no.4
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• pp.341-354
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• 2018

The one of the principles described in ICH E9 is that only results obtained from pre-specified statistical methods in a protocol are regarded as confirmatory evidence. However, in multi-regional clinical trials, even when results obtained from pre-specified statistical methods in protocol are significant, it does not guarantee that the test treatment is approved by regional regulatory agencies. In other words, there is no so-called global approval, and each regional regulatory agency makes its own decision in the face of the same set of data from a multi-regional clinical trial. Under this situation, there are two natural methods a regional regulatory agency can use to estimate the treatment effect in a particular region. The first method is to use the overall treatment estimate, which is to extrapolate the overall result to the region of interest. The second method is to use regional treatment estimate. If the treatment effect is completely identical across all regions, it is obvious that the overall treatment estimator is more efficient than the regional treatment estimator. However, it is not possible to confirm statistically that the treatment effect is completely identical in all regions. Furthermore, some magnitude of regional differences within the range of clinical relevance may naturally exist for various reasons due to, for instance, intrinsic and extrinsic factors. Nevertheless, if the magnitude of regional differences is relatively small, a conventional method to estimate the treatment effect in the region of interest is to extrapolate the overall result to that region. The purpose of this paper is to investigate the effects produced by this type of extrapolation via estimations, followed by hypothesis testing of the treatment effect in the region of interest. This paper is written from the viewpoint of regional regulatory agencies.

• Informatization Policy
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• v.25 no.1
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• pp.60-81
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• 2018

Healthcare is on the verge of a paradigm shift towards an emphasis on wellbeing, integrative health, and prevention of disease, while the traditional medical model focuses solely on end-point treatment. The development of digital technologies has played a major role in this change as digital technology and health have converged. Therefore, many developed countries promote the digital healthcare industry as a new economic growth engine, and Korea is no exception. To promote the digital healthcare industry, the Korean government provides institutional support by improving the legal and regulatory system for medical devices and health data. However, Korea still has an underdeveloped legal and regulatory framework for digital healthcare compared with other countries. In this study, we review the relevant regulatory systems in the United States, United Kingdom, Germany, and Japan. We then explore newspaper articles and conduct expert interviews to analyze the regulatory situation in Korea and the problems the digital healthcare industry faces. In conclusion, we discuss a regulatory reform plan for development of the digital healthcare industry in Korea.

• Korean Journal of Clinical Pharmacy
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• v.16 no.2
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• pp.123-130
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• 2006

The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.

• Journal of Soil and Groundwater Environment
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• v.22 no.3
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• pp.1-9
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• 2017

The numerical analysis of groundwater flow is indispensable for predicting problems associated with water resource development, civil works, environmental hazards, and nuclear power plant construction. Korea lacks public regulatory procedures and guidelines for groundwater flow modeling, especially in nuclear facility sites, which makes adequate evaluation difficult. Feasible step-by-step guidelines are also unavailable. Consequently, reports on groundwater flow modeling have low-grade quality and often present controversial opinions. Additionally, without public guidelines, maintaining consistency in reviewing reports and enforcing laws is more challenging. In this study, the guidelines for groundwater flow modeling were reviewed for three countries - the United States (Documenting Groundwater Modeling at Sites Contaminated with Radioactive Substances), Canada (Guidelines for Groundwater Modelling to Assess Impacts of Proposed Natural Resource Development Activities), and Australia (Australian Groundwater Modelling Guidelines), with the aim of developing groundwater flow modeling regulatory guidelines that can be applied to nuclear facilities in Korea, in accordance with the Groundwater Act, Environmental Impact Assessment Act, and the Nuclear Safety Act.

• Nuclear Engineering and Technology
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• v.51 no.7
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• pp.1791-1798
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• 2019

Instrumentation and Control (I&C) systems of nuclear power plants (NPPs) have been continuously digitalized. These systems have a critical role in the operation of nuclear facilities by functioning as the brain of NPPs. In recent years, as cyber security threats to NPP systems have increased, regulatory and policy-related organizations around the world, including the International Atomic Energy Agency (IAEA), Nuclear Regulatory Commission (NRC) and Korea Institute of Nuclear Nonproliferation and Control (KINAC), have emphasized the importance of nuclear cyber security by publishing cyber security guidelines and recommending cyber security requirements for NPP facilities. As described in NRC Regulatory Guide (Reg) 5.71 and KINAC RS015, challenge response authentication should be applied to the critical digital I&C system of NPPs to satisfy the cyber security requirements. There have been no cases in which the most robust response authentication technology like challenge response has been developed and applied to nuclear I&C systems. This paper presents a challenge response authentication mechanism for a Programmable Logic Controller (PLC) system used as a control system in the safety system of the Advanced Power Reactor (APR) 1400 NPP.

• Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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• v.14 no.3
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• pp.279-287
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• 2016

Korea Radioactive Waste Agency (KORAD) began to operate the low and intermediate level radioactive waste disposal facility in Gyeongju and to transport the radioactive waste containing radioactive isotopes from Daejeon to the disposal facility for the first time at 2015. For this radioactive waste transportation, in this study, radiological impact assessment is carried out for workers and public. The dose rate to workers and public during the transportation is estimated with consideration of the transportation scenarios and is compared with the Korean regulatory limit. The sensitivity analysis is carried out by considering both the variation of release ratios of the radioactive isotopes from the waste and the variation of the distances between the radioactive waste drum and worker during loading and unloading of radioactive waste. As for all the transportation scenarios, radiological impacts for workers and public have met the regulatory limits.

• Journal of Veterinary Clinics
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• v.35 no.1
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• pp.1-6
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• 2018

This study reviewed the regulatory safety management system for prevention of side effects of veterinary medical devices in Korea based on data obtained through analyses of those medical devices. In order to ensure the safety of medical devices, Ministry of Food and Drug Safety has established the management system include licensing, test inspection (134 designated clinical trial agencies) and post management. In addition, it was introduce the good manufacture practice (GMP) certification system and device tracking requirements. In contrast, it is necessary to establish regulations for side effects report and awareness on veterinary medical devices in Korea. The center for veterinary medicine of FDA in the United States has been operated side effects reporting system of veterinary medical devices from user, manufactures and distributor. Due to increase the use of various kinds of veterinary medical devices for animals, it should be required to improve regulation related to the licensing procedures, GMP system, and the side effects reporting system in our country.

• Proceedings of the Korean Society for Bioinformatics Conference
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• 2005.09a
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• pp.421-426
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• 2005

In this paper, we investigate the nonlinear dynamic behavior of TPP (thiamine pyrophosphate) riboswitches in E. coli (Escherichia coli). TPP riboswitches are highly conserved RNA regulatory elements, embedded within the 5’'untranslated region of three TPP biosynthesis operons. The three operons thiCEFSGH, thiMD, and thiBPQ are involved in the biosynthesis, salvage, and transport of TPP, respectively. TPP riboswitches modulate their expressions in response to changing TPP concentration, without involving protein cofactors. Interestingly, the expression of thiMD is regulated at the translational level, while that of thiCEFSGH at both levels of transcription and translation. We develop a mathematical model of the TPP riboswitch’s regulatory system possessed by thiCEFSGH and thiMD, so as to simulate the time-course experiments of TPP biosynthesis in E. coli. The simulation results are validated against three sets of reported experimental data in order to gain insight into the nature of steady states and the stability of TPP riboswitches, and to explain the biological significance of regulating at level of transcription or translation, or even both. Our findings suggest that in the TPP biosynthesis pathway of E. coli, the biological effect of down-regulating thiCEFSGH operon at the translational level by TPP riboswitch is less prominent than that at the transcriptional level.

• 대한예방의학회:학술대회논문집
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• 1994.02a
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• pp.450-468
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• 1994

Scientists have long used conventional toxicological methods to establish 'safe levels of exposure' for chemicals presumed to have threshold health effects or doses below which significant effects are unlikely to occur. These same methods cannot be used to establish safe levels of exposure for non-threshold pollutants. such as carcinogens. Therefore. Federal regulatory agencies in the United States are using risk assessment methods to provide information for public health policy decisions concerning increases in risk associated with increases in exposure to carcinogenic and other non-threshold pollutants. Acceptable exposure/risk levels are decided by policymakers who consider descriptions and estimates of risks together with social and economic benefits from the uses of the chemical. 1bis paper focuses on the development of quantitative risk assessment approaches by Federal regulatory agencies in the United States, and identifies the mathematical models currently being used for risk extrapolation. including their inherent uncertainties. The uncertainties and limitations of these methods have led some scientists to question the utility of quantitative risk extrapolation. The experience of the; U.S. Environmental Protection Agency (EPA). as summarized in this paper. can provide a realistic basis for evaluating the pros and cons. Finally. shortcomings in current risk assessment methods and their use in policy decisions are explored. and areas for possible improvement. given current scientific knowledge. are identified.