• Asian Journal of Business Environment
• /
• v.7 no.2
• /
• pp.5-16
• /
• 2017

Purpose - The purpose of this research study is to make a comparative analysis between corporate governance guidelines 2016 and 2012 and area of further improvement to ensure better governance, accountability and transparency. Research design, data and methodology - This research study is mainly based on the corporate governance guidelines 2016 and 2012 issued by the regulatory authority known as Bangladesh Securities and Exchange Commission (BSEC). Results - This study finds that corporate governance guideline 2012 include some new issues such as criteria and qualification of independent director; some additional statements in the directors' report; mandatory requirement of separation of chairman and CEO; constitution of audit committee; chairman of audit committee; role of audit committee, duties of CEO and CFO on financial statements; and collection of compliance certificate from professional accountant or secretary in compare to corporate governance guidelines 2016. Conclusions - This study suggests that the regulatory authority should include more issues such as tax management and reporting, risk management and reporting; individual and overall performance analysis of the board and independent directors; separate nomination and compensation committee; assessment of true independence of the board and its supporting committees to ensure higher quality of corporate governance and transparency.

• Journal of Korean Society of Occupational and Environmental Hygiene
• /
• v.30 no.2
• /
• pp.99-108
• /
• 2020

Objectives: This study aimed to compare the regulatory systems for laboratory safety and health management between Korea and Germany and discuss the implications. Methods: Laboratory safety and health regulations for legal enforcement and relevant technical guidelines in Korea and Germany were reviewed. Results: Lab safety and health management is enforced by the Act on the Establishment of Safe Laboratory Environment in Korea. Most provisions focus on supervisory control, that is, the principal's liability is emphasized. In addition, there is a lack of laboratory-specific procedures for safety and health management in the act since it is stipulated that other relevant regulations apply to some technical contents. Non-compulsory technical guidelines for lab safety and health management are also provided by the Korea Occupational Safety and Health Agency (KOSHA) in order to enable researchers to follow safe procedures. There is no independent regulation for lab safety and health in Germany, and it is also governed by several regulations. The German Social Accident Insurance Institute provides technical guidelines on lab safety and health, and these contain more specific content to allow them to be followed more easily compared to the KOSHA guidelines. The most remarkable differences between the regulation of each country were contents of the risk assessment and specific protect measures from hazardous agents. Conclusions: Regulatory control is an essential way to prevent accidents, but it is more important to create an environment in which all stakeholders, including individual lab members, are allowed to participate actively in safety and health management activities.

• Journal of Integrative Natural Science
• /
• v.4 no.4
• /
• pp.315-322
• /
• 2011

This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the approval of stereoisomeric drugs in Korea and US. According to the regulatory guidelines in major countries (EU, Canada, US), the important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substances 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. For this study, domestic regulatory documents for current guidelines of stereoisomeric drugs were investigated. Also four typical stereoisomeric drugs for three categories were chosen to investigate the new drug submission documents of KFDA and FDA for the safety and efficacy evaluation of stereoisomeric drugs. It is expected that these comparative results between KFDA and FDA will be useful for the safety and efficacy for the regulatory approval of stereoisomeric drugs in Korea.

• Journal of Korea Society of Digital Industry and Information Management
• /
• v.16 no.1
• /
• pp.99-109
• /
• 2020

In the past, conservative concepts have been applied in terms of the characteristic of nuclear power plants(NPPs), resulting in analog-based equipment and closed networks. However, as digital technology has recently been applied to the design, digital-based facilities and communication networks have been used in nuclear power plants, increasing the risk of cybersecurity than using analog-based facilities. Nuclear power plant facilities are divided into a safety system and a non-safety system. It is essential to identify the difference and cope with cybersecurity threats to the safety system according to its characteristics. In this paper, we examine the cybersecurity regulatory guidelines for safety systems in nuclear power plant facilities. Also, we analyze cybersecurity threats to a programmable logic controller of the safety system and suggest cybersecurity requirements be applied to it to respond to the threats. By implementing security functions suitable for the programmable logic controller according to the suggested cybersecurity requirements, regulatory guidelines can be satisfied, and security functions can be extended according to other system requirements. Also, it can effectively cope with cybersecurity attacks that may occur during the operation of nuclear power plants.

• Nuclear Engineering and Technology
• /
• v.55 no.1
• /
• pp.25-36
• /
• 2023

Nuclear power plants have recognized the importance of nuclear cybersecurity. Based on regulatory guidelines and security-related standards issued by regulatory agencies around the world including IAEA, NRC, and KINAC, nuclear operating organizations and related systems manufacturing organizations, design companies, and regulatory agencies are considering methods to prepare for nuclear cybersecurity. Cryptographic algorithms have to be developed and applied in order to meet nuclear cybersecurity requirements. This paper presents methodologies for validating cryptographic algorithms that should be continuously applied at the critical control system of I&C in NPPs. Through the proposed schemes, validation programs are developed in the PLC, which is a critical system of a NPP's I&C, and the validation program is verified through simulation results. Since the development of a cryptographic algorithm validation program for critical digital systems of NPPs has not been carried out, the methodologies proposed in this paper could provide guidelines for Cryptographic Module Validation Modeling for Control Systems in NPPs. In particular, among several CMVP, specific testing techniques for ECB mode-based block ciphers are introduced with program codes and validation models.

• Proceedings of the KSME Conference
• /
• 2003.04a
• /
• pp.610-616
• /
• 2003

Recently, the common concern of nuclear power industry in the development of technology mitigating and preventing the aging of steam generator tubes prevails, because the trends of steam generator flaws at Uljin unit #1,2 and KSNP(Korea Standard Nuclear Power Plant) impose a burden on the operation of nuclear power plant. While the regulatory agency is demanding the establishment of the advanced general performance maintenance system, the steam generator management program adapting advanced technology is being developed which may comply with EPRI PWR SG Guidelines based on NEI 97-06 ‘ General Guidelines including all the maintenance aspects consist of the tube integrity assessment criteria, repair limit, allowable leakage level, water chemistry will be composed in order to obtain the approval of regulatory agency and be applied to Nuclear power plant early 2005. This presentation is to introduce maintenance state including SG tube degradation and main contents of advanced SG management program being developed, and futhermore update present and future plan, and estimate the alternation after the completion.

• Proceedings of the Korean Institute of Building Construction Conference
• /
• 2018.05a
• /
• pp.318-319
• /
• 2018

Protective coatings at nuclear power plants should be designed to withstand exposure to ambient conditions during normal operation or design-basis accidents. However, there was a change in the perception of the protective coating to the revision of the Regulatory Guidelines by the NRC in July 2000. In other words, maintenance guidelines have been strengthened in order to minimize the clogging of the cooling water system due to the substances in the containment building. Therefore, KHNP, the contractor and operator of the nuclear power plant, plans to develop the coating system for nuclear power plants in accordance with the regulation, and plans to develop its own coating expert.

• Toxicological Research
• /
• v.21 no.4
• /
• pp.271-278
• /
• 2005

Reproductive and developmental toxicology is concerned with various physical or chemical agents interfering with fertility in both gender or normal growth of offsprings. Reproductive and developmental toxicology is rather a complex science, with many fields, i.e., various endpoints are involved and many different mechanisms of action. For that reason, diverse aspects must be considered when attempting to assess possible adverse health effects in the area of reproductive and developmental toxicology. The thalidomide tragedy made it clear to regulatory authorities around the world that systematic, comprehensive evaluation of the reproductive cycle was needed to adequately evaluate the potential of medicinal drugs to impair the process of reproduction or the development of embryos, fetuses, and children. International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) and U.S. Food and Drug Administration (FDA) developed a guideline to assess the reproductive and developmental toxicity. Also these guidelines have since been applied to the detection and regulation of environmental toxicants, food additives, and so on. Although it was hoped that testing procedures of guideline would be updated constantly to reflect the current state of the science in reproductive and developmental toxicology, it was not until this decade that regulatory guidelines and testing methods have been altered in a significant way. In this paper, we would like to present the recommended approaches and recent trends for improvement of testing guidelines or experimental methods in reproductive and developmental toxicology.

• Journal of Environmental Impact Assessment
• /
• v.2 no.2
• /
• pp.95-103
• /
• 1993

EIA has been introduced as a tool for environment protection into promulgation of the Environment Preservation Act in 1977, which replaced the Pollution Control Act in Korea. EIA system has been improved with the enlargement of project type, public participation, guideline improvement, and regulatory development. Recently, Environmental Impact Assessment(EIA) Act will have an important role for sustainable development. This article deals with regulatory development, implementation order, EIA project type, and EIS preparation guidelines by Act promulgated and amended, also it explains comparison analysis of Environmental Policy Act and Environment Impact Assessment Act Major results are summarized in the table.

• Proceedings of the PSK Conference
• /
• 2003.10a
• /
• pp.28-28
• /
• 2003

After approval, the drug should be manufactured and maintained with uniform quality. To assure the quality of drugs, the drug companies should comply with GMP guidelines and regulatory authorities should assess their compliance. In this article, I want to review the definition of drugs as well as the quality surveillance system. To be controlled as drugs, they ought to have their own specifications and test methods. (omitted)