Статті в журналах: "Regulatory requirement"

1

Saufl, Nancy M., and Margaret H. Fieldus. "Accreditation: a “voluntary” regulatory requirement." Journal of PeriAnesthesia Nursing 18, no. 3 (June 2003): 152–59. http://dx.doi.org/10.1016/s1089-9472(03)00087-x.

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Maerani, Restu, Tulis Jojok Suryono, and Muhammad Subekti. "REQUIREMENT ANALYSIS OF COMPUTER-BASED INSTRUMENTATION AND CONTROL SYSTEM FOR REAKTOR DAYA EKSPERIMENTAL." JURNAL TEKNOLOGI REAKTOR NUKLIR TRI DASA MEGA 21, no. 1 (March 11, 2019): 39. http://dx.doi.org/10.17146/tdm.2019.21.1.5312.

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Developing and licensing of digital Instrumentation and control (I&C) system for nuclear power plant (NPP) are challenging especially for the new construction since digital technology are composite with a very high complexity of many integrated systems. National Nuclear Energy Agency of Indonesia (BATAN), who design Reaktor Daya Eksperimental (RDE), should prepare the documents to meet the licensing requirements of national regulator in this case Nuclear Energy Regulatory Agency of Indonesia (BAPETEN). BAPETEN’s chairman regulation No.6 year of 2012 is the first national requirement which state requirements related to design of computer-based system concerning on safety of power reactor that should be followed. Since BAPETEN only denotes requirements without state which code and standards to be used, therefore BATAN can add references from International Nuclear Energy Agency (IAEA) guidelines. In this paper, requirement document traceability is developed to determine which code and standards should be used to verify and validate the I&C computer-based system of RDE. The hierarchy of regulatory and utility requirements are developed to guide the design basis documentation. Developing requirements analysis of computer-based I&C system RDE are completed after determining the design requirements from the utility and regulatory requirements. This methodology will help the design engineers to follow the utility requirements by concerning to the production, and follow the regulatory requirements concerning the safety aspect.Keywords: Computer-based system, I&C System, Requirements analysis, Licensing, RDE

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3

Pojasek, Robert B. "Is sustainability becoming a regulatory requirement?" Environmental Quality Management 19, no. 4 (June 10, 2010): 83–90. http://dx.doi.org/10.1002/tqem.20264.

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4

Badjatya, Jitendra Kumar, Anil Jangid, Prakash Dodiya, Saurabh Soni, Akshita Parekh, Deval Patel, and Jaimin Patel. "Comparative study of Regulatory requirements of Drug Product in Emerging market." International Journal of Drug Regulatory Affairs 10, no. 1 (March 15, 2022): 51–82. http://dx.doi.org/10.22270/ijdra.v10i1.510.

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Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety. The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.

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5

Patel, Preeti, Jitendra Kumar Badjatya, and Madhuri Hinge. "Comparative study of Regulatory requirements of Drug Product in Emerging market." International Journal of Drug Regulatory Affairs 7, no. 3 (September 15, 2019): 48–62. http://dx.doi.org/10.22270/ijdra.v7i3.350.

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Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety.The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.

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6

Hasan, M. Mahmudul, Dimosthenis Anagnostopoulos, George Kousiouris, Teta Stamati, Peri Loucopoulos, and Mara Nikolaidou. "An Ontology based Framework for E-Government Regulatory Requirements Compliance." International Journal of E-Services and Mobile Applications 11, no. 2 (April 2019): 22–42. http://dx.doi.org/10.4018/ijesma.2019040102.

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E-Government has gained an enormous amount of attention by researchers and practitioners interested in digitizing the public sector through enacting policies and regulations. Compliance of regulatory requirements from these policies and regulations is an important requirement in e-Government service development projects. However, the concepts of regulatory requirements compliance are still scattered around in developing e-Government services. This article presents an e-Government regulatory requirement compliance (eGRRC) ontology framework that describes the interrelated concepts of regulatory requirements compliance in e-Government service development. The proposed eGRRC ontology is then applied on the recently introduced general data protection regulation (GDPR) for personal data processing across European Union (EU) countries, in order to indicate how the concepts can be mapped to the defined entities. The contribution of this article is on introducing a framework for researchers and practitioners to explore regulatory requirements compliance and their interrelationships in e-Government service development. Furthermore, e-Government legislation can accordingly be modeled using on the eGRRC ontology, that serves as basis for queries to infer knowledge about the source of regulatory requirements, objectives of the regulation, various types of requirements, the services affected, orientation of regulatory rules in requirements, priorities, and amendments of regulations in e-Government service development.

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7

Subramanian, Ajay, and Baozhong Yang. "Dynamic Prudential Regulation." Management Science 66, no. 7 (July 2020): 3183–210. http://dx.doi.org/10.1287/mnsc.2019.3333.

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We analyze the design and impact of bank regulation using a dynamic structural framework. The optimal regulatory policy combines a target capital requirement, the mitigation of underinvestment, an intervention capital requirement to control inefficient risk taking, and recapitalization of distressed banks. The optimal target and intervention capital requirements from our structural estimation are consistent with the substantially higher capital requirements proposed in Basel III and together achieve most of the regulatory benefits by alleviating underinvestment and asset substitution. They are interdependent and respond differently to banks’ asset characteristics, thereby suggesting that regulatory policies should be carefully tuned to the economic environment. This paper was accepted by Kay Giesecke, finance.

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8

T. Jacques, Kevin. "Capital regulations, supervision and the international harmonization of bank capital ratios." Banks and Bank Systems 12, no. 1 (June 19, 2017): 175–83. http://dx.doi.org/10.21511/bbs.12(1-1).2017.11.

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In recent decades, despite the Basel Committee’s effort to develop internationally uniform regulatory capital standards, the capital ratios of banks across countries continue to exhibit significant differences. This paper examines the fundamental question of whether, given a uniform regulatory capital standard, regulators should expect similar banks to exhibit similar risk-based capital ratios. More specifically, this study develops a one-period theoretical model to examine the level playing field argument in light of not only uniform regulatory capital standards but also differences in bank supervision. The results of the theoretical model suggest that even with an internationally uniform risk-based capital requirement, it is unreasonable to expect banks in different countries to hold similar capital ratios. This occurs, in part, because regulators have discretion in how they apply the risk-based capital standards. Furthermore, the results suggest that a necessary condition for banks to exhibit similar capital ratios is that uniform capital requirements must be accompanied by a uniform stringency and application of regulatory supervision.

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9

Jain, Achin, Venkatesh M. P., Raja Mohan Reddy.G, and Pramod Kumar T.M. "REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND." International Journal of Drug Regulatory Affairs 3, no. 1 (February 13, 2018): 62–74. http://dx.doi.org/10.22270/ijdra.v3i1.158.

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The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries vary from each other. Therefore, it is challenge for the companies to get drug approved for marketing simultaneously in different countries. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of medicines in their country. It not only includes the process of regulating and monitoring the drugs, but also the process of manufacturing, distribution, and promotion. The regulatory environment has similar characteristics, but drug registration requirements and processes differ among the countries. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. In ASEAN region, documentation can be filed in the ACTD format. Even though ACTD format is mandatory from 2009, the member countries have their own requirements for registration process like administrative documents, labeling. The purpose of this paper is to give a comparative overview on the Drug regulatory requirement for generics in two of the ASEAN countries which are Singapore and Thailand.

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10

Okinaga, Toshinori, Guoqing Niu, Zhoujie Xie, Fengxia Qi, and Justin Merritt. "The hdrRM Operon of Streptococcus mutans Encodes a Novel Regulatory System for Coordinated Competence Development and Bacteriocin Production." Journal of Bacteriology 192, no. 7 (January 29, 2010): 1844–52. http://dx.doi.org/10.1128/jb.01667-09.

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ABSTRACT The Streptococcus mutans hdrRM operon encodes a novel two-gene regulatory system induced by high cell density. Previous studies identified hdrM as the only known negative regulator of competence development in S. mutans. In the present study, we demonstrated that the HdrRM system bypasses the prototypical competence gene regulators ComC and ComDE in the transcriptional regulation of the competence-specific sigma factor comX and the late competence genes. Similarly, the HdrRM system can abrogate the requirement for ComE to produce the bacteriocin mutacin IV. To further probe the regulatory mechanism of hdrRM, we created an hdrR overexpression strain and showed that it could reproduce each of the hdrM competence and mutacin phenotypes, indicating that HdrM acts as a negative regulator of HdrR activity. Using a mutacin IV-luciferase reporter, we also demonstrated that the hdrRM system utilizes the same promoter elements recognized by ComE and thus appears to comprise a novel regulatory pathway parallel to ComCDE.

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11

doCarmo, AnaCerúlia Moraes, Marcilio S. S. Cunha-Filho, Guilherme Martins Gelfuso, and Tais Gratieri. "Evolution of quality on pharmaceutical design: regulatory requirement?" Accreditation and Quality Assurance 22, no. 4 (May 26, 2017): 199–205. http://dx.doi.org/10.1007/s00769-017-1270-z.

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12

Sampson, Mark E. "1.3.4 Web-based Requirement Management and Regulatory Tracking." INCOSE International Symposium 8, no. 1 (July 1998): 325–30. http://dx.doi.org/10.1002/j.2334-5837.1998.tb00047.x.

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13

Astakhov, Sergey Yu, and Svyatoslav L. Plavinskii. "Endpoints selection in registration clinical trials and the needs of real-world clinical practice with the example of anti-VEGF therapy in neovascular age-related macular degeneration." Ophthalmology Journal 14, no. 1 (June 9, 2021): 25–33. http://dx.doi.org/10.17816/ov63571.

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The issues of endpoints selection for regulatory requirements and real-world clinical practice using the example of anti-VEGF therapy in neovascular age-related macular degeneration (nAMD) are discussed in the article. New technologies (optical coherent tomography) introduction are shown to change clinical practice but not regulatory requirements on the endpoints. In the same time for regulatory purpose clinical trials design is changed from superiority to non-inferiority. The changes in the approach to primary endpoint selection are not anticipated due to regulators conservatism but there is a requirement to the comparison with best treatment alternative (i.e. same class comparator in case of anti-VEGF therapy) due to ethical reasons. To satisfy real-world clinicians need, the secondary endpoints are analyzed, but multiple testing problem appears. Statistical methods developed in recent years allow using specified comparison to be made without inflating Type I error. HAWK and HARRIER clinical trials demonstrated an example how superiority of brolucizumab over aflibercet on anatomical endpoints was reliably found.

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14

Kenney, M. L. "Laboratory performance and regulatory requirements." Clinical Chemistry 33, no. 6 (June 1, 1987): 1087–102. http://dx.doi.org/10.1093/clinchem/33.6.1087.

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Abstract We compared performance levels of four clinical laboratory groups defined by federal regulatory characteristics, to assess the appropriateness of selected regulations: laboratories in JCAH-accredited hospitals; non-doctoral-directed independent laboratories; state-regulated but federally exempt group-practice laboratories; and unregulated laboratories in physicians' offices (POLs). Federal regulations evaluated were those dealing with the doctoral directorship requirement and exemption of POLs from regulation. Quantitative analytes were compared by using linear regression on log-normal transformations of mean absolute-z scores of proficiency test results. The scope of services offered by laboratories was statistically related to performance in quantitative analytes. Confounding effects of scope-of-service levels were statistically controlled. Proportions of errors in qualitative analytes were compared. No pattern of statistically discernible differences in performance was found between hospital laboratories and non-doctoral-directed laboratories. Both regulated non-doctoral-directed laboratories and state-regulated but federally exempt group-practice laboratories demonstrated higher levels of performance than unregulated POLs.

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15

Songara, Rajendra Kumar, Pratibha Chouhan, Rajeev K Singla, Ajay Tiwari, and Anuj Sharma. "Regulatory Aspect of International Organization for Standardization (ISO)." Indo Global Journal of Pharmaceutical Sciences 01, no. 03 (2011): 258–80. http://dx.doi.org/10.35652/igjps.2011.26.

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ISO specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion and are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. © 2011 IGJPS. All rights reserved.

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16

Sun, Si Zhong. "The Impact of Fine Aggregate on the Porosity of Asphalt." Advanced Materials Research 1065-1069 (December 2014): 814–17. http://dx.doi.org/10.4028/www.scientific.net/amr.1065-1069.814.

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With different fine aggregate, gradation type, oil stone ratio, asphalt type specimen molding and molding method and calculate the porosity of the specimen. The experimental results show that the using basalt coarse aggregate and fine aggregate forming specimen, specimen porosity significantly larger, all are beyond the scope of regulatory requirements; If using basalt coarse aggregate and limestone fine aggregate forming specimens, specimen porosity is small, both meet regulatory requirements. The main reason is basalt fines aggregate bulk volume density is too large and not easily compacted. Recommendation: we’d better use of basalt coarse aggregate and limestone fine aggregate forming specimen, try to avoid using basalt aggregate thickness of molded specimen. If the region lacks limestone fines, we should detect the special type of basalt fine aggregate firstly. If the indicators of basalt fines are in line with the requirement, you can use, if the indicators do not meet regulatory requirement, you can not use.

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17

MORIMOTO, Toshio, and Tetsuo SAWADA. "Requirement for Qualification and Expertise of Nuclear Regulatory Body." Journal of the Atomic Energy Society of Japan 53, no. 12 (2011): 826–30. http://dx.doi.org/10.3327/jaesjb.53.12_826.

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18

Singam, Sri Lakshmi Sowjanya Reddy, Koushik Yetukuri, and Rama Rao Nadendla. "Drug Registration requirements for Pharmaceuticals in Emerging markets." International Journal of Drug Regulatory Affairs 8, no. 4 (December 17, 2020): 73–82. http://dx.doi.org/10.22270/ijdra.v8i4.442.

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Registration of pharmaceutical drug products in emerging market is maximum worrying task. Although the requirements are harmonized in regulated international locations by way of CTD (Common technical document) submitting, yet others have considerable diversity in necessities. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe collectively for various factors of drug registration. But there is no such harmonized guideline for rising marketplace besides Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exists in clusters with their mutual situation. Quality, Safety and Efficacy information has significance importance in dossier registration. Pharmaceutical Industries has to conform with regulatory requirement in Emerging market and for betterment of public Health and protection. The business importance of markets is increasing globally. It is important for pharmaceutical enterprise to address the regulatory necessities for betterment of public and to ensure their place in the marketplace. The review additionally explains a short approximately extraordinary regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier software in Emerging marketplace.

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19

Li, Tzu-Wei, Pei-Weng Tu, Li-Ling Liu, and Shiow-Ing Wu. "Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan." BioMed Research International 2015 (2015): 1–7. http://dx.doi.org/10.1155/2015/670420.

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The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.

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20

Yang, Yimin, and Min Wu. "Basel regulatory capital formula revised." International Journal of Financial Engineering 08, no. 03 (July 12, 2021): 2142006. http://dx.doi.org/10.1142/s2424786321420068.

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Credit capital requirement is a key component of Basel implementation to assess a bank’s capital adequacy. Under the Internal Rating-Based approach, some risk parameters, including Asset Correlation, are implicit assumptions that cannot be observed directly. While some heuristic formulae of Asset Correlation for different business segments are provided by Basel, they may not be fully consistent with each bank’s loss experience and thus may cause systematic underestimation of banks’ capital requirement. To address this issue, we derive an equivalent capital formula in such way that the unobservable Asset Correlation is replaced by an observable and well-understood parameter called Default Volatility, which can be calibrated based on banks’ historical loss experience. This new approach simplifies parameter estimation process without requiring additional data, as well as making risk analysis such as stress testing more credible.

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21

Hasmin, Nor Akhmal, Zinatul Ashiqin Zainol, Rahmah Ismail, and Anida Mahmood. "Regulatory Challenges of Nanofood Labelling." Journal of Politics and Law 13, no. 2 (May 30, 2020): 241. http://dx.doi.org/10.5539/jpl.v13n2p241.

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This article examines four regulatory challenges of nanofood labelling from the domestic context namely, scientific uncertainties shrouded the tiny particles, absence of a harmonised legal definition, detection issue of nanomaterials in a final product, and complexity in implementation and enforcement. This article also offers discussion on the possible ways to overcome these challenges. It establishes that mandatory labelling can be implemented within Malaysia food regulatory framework. It can be done by narrowing the labelling requirement to food with engineered nanomaterials (ENMs), adopting the precautionary principle, clarify the legal definition of ENMs for food law, robust techniques to detect, measure, and characterize diverse ENMs in food matrices, and strengthen the enforcement institutions. Importantly, this study hopes to significantly contribute to improving the legal provisions on food information system for a product of emerging technology such as nanofood by pushing forward the legal requirement for nanofood labelling.

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22

Choi, Jeongjoon, and Eduardo A. Groisman. "Horizontally acquired regulatory gene activates ancestral regulatory system to promote Salmonella virulence." Nucleic Acids Research 48, no. 19 (October 12, 2020): 10832–47. http://dx.doi.org/10.1093/nar/gkaa813.

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Abstract Horizontally acquired genes are typically regulated by ancestral regulators. This regulation enables expression of horizontally acquired genes to be coordinated with that of preexisting genes. Here, we report a singular example of the opposite regulation: a horizontally acquired gene that controls an ancestral regulator, thereby promoting bacterial virulence. We establish that the horizontally acquired regulatory gene ssrB is necessary to activate the ancestral regulatory system PhoP/PhoQ of Salmonella enterica serovar Typhimurium (S. Typhimurium) in mildly acidic pH, which S. Typhimurium experiences inside macrophages. SsrB promotes phoP transcription by binding upstream of the phoP promoter. SsrB also increases ugtL transcription by binding to the ugtL promoter region, where it overcomes gene silencing by the heat-stable nucleoid structuring protein H-NS, enhancing virulence. The largely non-pathogenic species S. bongori failed to activate PhoP/PhoQ in mildly acidic pH because it lacks both the ssrB gene and the SsrB binding site in the target promoter. Low Mg2+ activated PhoP/PhoQ in both S. bongori and ssrB-lacking S. Typhimurium, indicating that the SsrB requirement for PhoP/PhoQ activation is signal-dependent. By controlling the ancestral genome, horizontally acquired genes are responsible for more crucial abilities, including virulence, than currently thought.

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23

Farooq, Uzma, Rishabha Malviya, and Pramod Sharma. "Investigation and Need of Bioequivalence Study: Methodology and Regulatory Requirement." Applied Clinical Research, Clinical Trials and Regulatory Affairs 1, no. 2 (November 28, 2014): 93–106. http://dx.doi.org/10.2174/2213476x01666140613221900.

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24

Poovarasan, D., K. Manikandan, and R. Kamaraj. "Regulatory Requirement and Registration Process of Generic Drugs in Japan." Research Journal of Pharmacy and Technology 13, no. 3 (2020): 1523. http://dx.doi.org/10.5958/0974-360x.2020.00277.2.

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25

Levine, Andrew G., Aaron Arvey, Wei Jin, and Alexander Y. Rudensky. "Continuous requirement for the TCR in regulatory T cell function." Nature Immunology 15, no. 11 (September 28, 2014): 1070–78. http://dx.doi.org/10.1038/ni.3004.

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26

Williamson, Andrew J. K., and Anthony D. Whetton. "The requirement for proteomics to unravel stem cell regulatory mechanisms." Journal of Cellular Physiology 226, no. 10 (July 22, 2011): 2478–83. http://dx.doi.org/10.1002/jcp.22610.

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27

Liang, Kai Qiao. "A Positive Study of Risk Behavior Based on Dynamic Panel Data." Applied Mechanics and Materials 522-524 (February 2014): 887–91. http://dx.doi.org/10.4028/www.scientific.net/amm.522-524.887.

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The paper studies risk behavior and capital buffers of Chinas commercial banks under capital regulatory whose core is capital adequacy ratio. We find that the regulatory pressure doesnt significantly affect the risk behavior of commercial banks. It doesnt affect the capital adjustment of commercial banks which have already violated regulatory capital requirement. Whereas, commercial bank which doesnt violate the regulatory requirement but approaching the threshold, will react to this pressure by fine-tuning of supplementary capital to increase its capital adequacy ratio.

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Ketele, Wondue, Tesfa Marew, Motlalepula Matsabisa, and Gebremariam Birhanu. "Regulatory Compliance of Small-Scale Pharmaceutical manufacturing facilities in Addis Ababa, Ethiopia." International Journal of Drug Regulatory Affairs 10, no. 3 (September 15, 2022): 1–9. http://dx.doi.org/10.22270/ijdra.v10i3.540.

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Background: there is growing concern that medicines supplied to most of the developing countries are of substandard quality. Along with the establishment of strong regulatory systems for ensuring compliance and regulatory law enforcement, manufacturing facilities need to work to implement dependable systems at each stage of the production process to ensure the safety, efficacy, and quality of their products. Objective: the aim of this study was to assess the level of compliance with regulatory requirements by small-scale pharmaceutical manufacturing facilities in Addis Ababa, Ethiopia. Material & Method: A cross-sectional observational study was conducted using a structured questionnaire and checklist to assess the level of compliance of small-scale local pharmaceutical manufacturing facilities to regulatory requirements and also to identify the challenges faced by the manufacturing facilities. Result: This study indicated that the overall implementation status of regulatory requirements in the local small-scale pharmaceutical manufacturing companies is far below the minimum standard set by WHO and the national regulatory authority. Basic on specific regulatory requirement elements compliance: requirements related to QA were 26.9, requirements related to personnel qualification were 38.1, requirements related to Quality control were 25.9, and requirements related to sanitation and hygiene were 15.3. Of the total regulatory requirements, only 26.1% were found to be implemented. Major challenges faced by the local small-scale pharmaceutical manufacturing industry for the implementation of regulatory requirements were: human resource capacity constraints, limited investment, limited support from Governments and other stakeholders, and poor infrastructure. Conclusion: The study demonstrated that level of regulatory requirements implementation in the local small-scale pharmaceutical manufacturers is far below the minimum standard set by the national regulatory authority. Important gaps were reported particularly in materials management, production operations, quality control, and sanitation and hygiene.

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Badjatya, Jitendra Kumar, and Ramesh Bodla. "DRUG PRODUCT REGISTRATION IN SEMI-REGULATED MARKET." International Journal of Drug Regulatory Affairs 1, no. 2 (February 6, 2018): 1–6. http://dx.doi.org/10.22270/ijdra.v1i2.3.

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There found a diversity of regulatory requirement in Semi regulated market. This region consists of mainly thecountries from Asia pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacificand Gulf have somewhat harmonized their regulatory environment through The Association of Southeast AsianNations (ASEAN) and Gulf Co-operation Council (GCC) organizations, ROW countries yet to be harmonizedregulations in their respective regions.The urgent requirement to rationalize & harmonize regulation was required by instance of rising cost of health care,research & development and to meet the public requirement for safe and efficacious treatments to patient in need.ICH committee has given priority to harmonize the format of reporting data for quality, safety and Efficacy in theapplication dossier.The commercial significance of ROW markets is increasing globally. It is crucial that pharmaceutical companies keepup-to-date with the latest regulatory developments to ensure their place on the ROW market.This paper favors the regulatory processes for gaining marketing authorization in ROW countries in terms oftechnical data requirement for the dossier.

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Mihok, S., and P. Thompson. "Regulatory experience in applying a radiological environmental protection framework for existing and planned nuclear facilities." Annals of the ICRP 41, no. 3-4 (October 2012): 256–62. http://dx.doi.org/10.1016/j.icrp.2012.06.024.

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Frameworks and methods for the radiological protection of non-human biota have been evolving rapidly at the International Commission on Radiological Protection and through various European initiatives. The International Atomic Energy Agency has incorporated a requirement for environmental protection in the latest revision of its Basic Safety Standards. In Canada, the Canadian Nuclear Safety Commission has been legally obligated to prevent unreasonable risk to the environment since 2000. Licensees have therefore been meeting generic legal requirements to demonstrate adequate control of releases of radioactive substances for the protection of both people and biota for many years. In the USA, in addition to the generic requirements of the Environmental Protection Agency and the Nuclear Regulatory Commission, Department of Energy facilities have also had to comply with specific dose limits after a standard assessment methodology was finalised in 2002. Canadian regulators developed a similar framework for biota dose assessment through a regulatory assessment under the Canadian Environmental Protection Act in the late 1990s. Since then, this framework has been applied extensively to satisfy legal requirements under the Canadian Environmental Assessment Act and the Nuclear Safety and Control Act. After approximately a decade of experience in applying these methods, it is clear that simple methods are fit for purpose, and can be used for making regulatory decisions for existing and planned nuclear facilities.

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Mihret, Dessalegn Getie, Monika Kansal, Mohammad Badrul Muttakin, and Tarek Rana. "The auditing profession and the key audit matter reporting requirement." Qualitative Research in Accounting & Management 19, no. 1 (December 30, 2021): 107–25. http://dx.doi.org/10.1108/qram-03-2020-0033.

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Purpose This study aims to examine the setting of International Standards on Auditing (ISA) 701 on disclosing key audit matters (KAMs) to explore the role of standard setting in maintaining or reconstituting the relationship of the auditing profession with preparers and users of financial reports. Design/methodology/approach This study draws on concepts from the sociology of the professions literature and the regulatory space metaphor. Data comprises comment letters and other documents pertaining to the setting of ISA 701. Findings The study shows that the KAM reporting requirement is part of the ongoing re-calibration of the regulatory arrangements governing auditing, which started in the early 2000s. This study interprets standard setting as a site for negotiating the relationships between linked ecologies in the audit regulatory space, namely, the auditing profession, preparers of financial statements and users of audited reports. This study identifies three processes involved in setting ISA 701, namely, reconstitution of the rules governing auditors’ reports as a link between the three ecologies, preserving boundaries between the auditing profession and preparers and negotiation aimed at balancing competing interests of the interrelated ecologies. Originality/value The study offers insights into the role of regulatory rule setting as a central medium through which the adaptive relationship of the profession with its environment is negotiated.

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Suryawanshi Meghraj and Jain minal. "An overview on comparative study of registration requirements for generics in US, Canada and Europe." International Journal of Research in Pharmaceutical Sciences and Technology 1, no. 4 (July 2, 2020): 117–23. http://dx.doi.org/10.33974/ijrpst.v1i4.196.

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Generic Drug Product approval is most stringent and crucial process for company with different rules and regulation in different country. For the registration of the product company has to follow regulatory rules and requirement of country specific agency. Company should apply product marketing authorization as per norms of country requirements and should manage life cycle of that product throughout market. Need to understand and describe the various regulatory requirements for the generic drug approval process and comparison of regulated country. To understand the technical requirements required to market medicines in regulated pharmaceutical market. To evaluate similarities and differences within regulated market of U.S, Canada, and Europe. To understand and evaluate differences of post approval Changes within regulated market.

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Maerani, R., T. J. Suryono, and S. Santoso. "Requirement analysis for human factor engineering on SMR-NuScale design." Journal of Physics: Conference Series 2193, no. 1 (February 1, 2022): 012062. http://dx.doi.org/10.1088/1742-6596/2193/1/012062.

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Abstract Human Factors Engineering (HFE) is an important element of control room facility design and Man Machine Interface (MMI) design whose principles must be applied systematically to ensure the safe operation of power reactors. In the design of the NuScale Small Modular Reactor (SMR), the United States-Nuclear Regulatory Commission (US-NRC) as an international regulatory body has published Design-Specific Review Standards (DSRS) for Nuclear SMR design which are specific for NuScale. There is no specific discussion related to HFE in the document. However, in order to develop the NuScale design in In Indonesia, we can learn from Oregon State University, the first Nuscale developer, regarding the requirements when those are compared to the large nuclear reactors. Therefore, reviewing the NuScale SMR design needs to be carried out starting with the conducting a requirement traceability analysis by tracing the guidelines from the regulatory body and knowing the recommended guideline in developing the HFE design, especially for the specific SMR/NuScale. It is hoped that by understanding the process of verifying these requirements documents, Indonesia will be able to apply the HFE for the NuScale reactor by meeting the criteria required by BAPETEN and be able to prepare the validation method so that the design can obtain a license.

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Liu, Yun, Li Zhang, Boshi Wang, Zhaojuan Yang, Guiqin Xu, Aihui Ma, Ming Tang, et al. "Requirement for POH1 in differentiation and maintenance of regulatory T cells." Cell Death & Differentiation 26, no. 4 (July 23, 2018): 751–62. http://dx.doi.org/10.1038/s41418-018-0162-z.

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Bakerjian, Debra. "Updates on quality assurance performance improvement regulatory requirement for nursing homes." Geriatric Nursing 34, no. 5 (September 2013): 428–32. http://dx.doi.org/10.1016/j.gerinurse.2013.07.011.

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Weir, Lindsay K., Kimberly Chin, Gail Potter-Bynoe, and Thomas J. Sandora. "Tabletop Sterilizers: Assessing and Monitoring Professional Standard and Regulatory Requirement Compliance." American Journal of Infection Control 44, no. 6 (June 2016): S27—S28. http://dx.doi.org/10.1016/j.ajic.2016.04.193.

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Pfeiffer, D. "TU-E-213AB-02: The Regulatory Path to Achieve QMP Requirement." Medical Physics 39, no. 6Part24 (June 2012): 3907. http://dx.doi.org/10.1118/1.4735948.

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Weber, Rolf H., and Aline Darbellay. "The regulatory use of credit ratings in bank capital requirement regulations." Journal of Banking Regulation 10, no. 1 (November 2008): 1–16. http://dx.doi.org/10.1057/jbr.2008.22.

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Galloway, Sheila. "Regulatory requirement for three dose levels in rodent genetic toxicity assays." Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis 329, no. 2 (July 1995): 213–19. http://dx.doi.org/10.1016/0027-5107(95)00026-f.

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Piercey, M. David. "Documentation Requirements and Quantified versus Qualitative Audit Risk Assessments." AUDITING: A Journal of Practice & Theory 30, no. 4 (November 1, 2011): 223–48. http://dx.doi.org/10.2308/ajpt-10171.

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SUMMARY The “not documented, not done” requirements of Public Company Accounting Oversight Board (PCAOB) Auditing Standard No. 3 substantially increased auditors' obligations to document their risk assessments. This study examines a potentially unintended consequence of such a requirement on auditors who have pressure to reach lenient, client-preferred risk assessments. Because documentation requirements potentially expose auditors' lenient judgments to more ex post scrutiny (e.g., regulator inspection, litigation), one would ordinarily not expect that adding them would cause auditors with client pressures to become more lenient. However, I expect that adding documentation requirements leads auditors who assess risk in qualitative (rather than quantified) terms to engage more in a specific word-smithing strategy that is shown by prior research to help rationalize reaching more lenient audit conclusions. Thus, even though documentation potentially exposes more lenient judgments to scrutiny, I show that auditors assessing risk in qualitative terms respond to this pressure by rationalizing their lenient assessments even more vigilantly. This leads to more lenient judgments, ironically, as a result of adding the documentation requirement. Adding documentation requirements does not have this effect on quantified risk assessments. Prior research also suggests that auditors typically assess risk in words. Thus, under common conditions, the PCAOB's documentation requirements may have unintended effects, with adverse implications for audit effectiveness contrary to their regulatory intent. Data Availability: Contact the author.

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Patel, Ravish, Amit Patel, and Tejasvini Gohil. "Regulatory requirement for the approval of Generic Drug in Cambodia as per ASEAN Common Technical Dossier (ACTD)." International Journal of Drug Regulatory Affairs 6, no. 2 (June 15, 2018): 67–71. http://dx.doi.org/10.22270/ijdra.v6i2.245.

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Drug approval process differs from one country to another country. In some countries only single body regulates the drug as well as responsible for all regulatory work which is a challenging task for the pharmaceutical companies to prepare single dossier that can be simultaneously submitted in many countries for approval. In all countries there is a similar characteristic in regulatory environment but there is a difference in their registration requirements. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Malaysia. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.

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Gaffey, Veronica. "Regulatory Scrutiny Board: A support for evidence-based policymaking in the European Commission." Evaluation 26, no. 2 (April 2020): 166–76. http://dx.doi.org/10.1177/1356389019897703.

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The European Commission has strengthened its requirements for impact assessment and evaluation over the years. In 2002, it introduced a requirement for impact assessments for new policy proposals and regulations. Such impact assessments had to define the need for European Union action and analyse a variety of options for action. In 2006, it established an Impact Assessment Board, made up of senior managers from across Commission directorates-general. The Board members worked part-time on the Board and did not sit in judgement on proposals from their own directorate-general.

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Rawlings, Samantha, John Lo Verde, and Wayland Dong. "Application of acoustical control through building codes and regulatory requirements." Journal of the Acoustical Society of America 151, no. 4 (April 2022): A34. http://dx.doi.org/10.1121/10.0010571.

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The International Building Code (IBC) establishes minimum acoustical performance requirements for permanent and transient housing facilities. The lab parameters for acoustical performance within the IBC are useful during the design and permitting process but fail to provide code officials, builders, designers, and residents a method for evaluating the success of a completed building. The latest update to the IBC in 2021 establishes standards and metrics for use in evaluating post-construction code compliance to mutually protect all stakeholders (builders, code officials, occupants, municipalities, etc.) in housing facilities and reduces historic ambiguity in the code. Historically, the nature of the metrics and their ability to evaluate success has been limited (“Field impact insulation testing: Inadequacy of existing normalization methods and proposal for new ratings analogous to those for airborne noise reduction,” LoVerde/Dong, JASA , 2005). There is some historic precedent regarding the application and measurement requirement for field metrics (“Coping with uncertainties in the design and evaluation ofacoustical assemblies,” LoVerde/Dong, ASA Hong Kong, 2012). This presentation expands this conversation to examine regulatory requirements and discusses application of field verification of acoustical performance metrics.

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Adesina, Kolade Sunday, and John Muteba Mwamba. "Linking bank regulatory capital buffer to business cycle fluctuations." Journal of Economic Studies 45, no. 3 (August 13, 2018): 565–85. http://dx.doi.org/10.1108/jes-05-2017-0112.

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Purpose The purpose of this paper is to assist bank regulators in Africa who are currently considering the implementation of Basel III countercyclical capital buffer (CCB) requirement. Design/methodology/approach Using a panel data set of 129 commercial banks operating in 14 African countries over the period 2004–2014, this paper estimates the system generalized method of moments regression to examine the impact of business cycle on banks’ regulatory capital buffers and attempts to identify the influence of bank revenue diversification, market power and cost of funding (CF) on bank regulatory capital buffers. It further carries out some robustness analyses using a panel data set of 257 commercial banks in 23 African countries over the period 2004–2014. Findings The results show that higher regulatory capital buffers are associated with higher market power, higher revenue diversification and higher CF. Additionally, the results show significant evidence of procyclical behavior of bank capital buffers (BUFs) in the sampled countries. Practical implications The results of this study suggest that African banking systems are not exposed to contagion and systemic risks arising from countercyclical movements of BUFs to the real economy. Therefore, this study does not support the implementation of the Basel III CCB requirement in the sampled African countries. Originality/value Considering that the results of existing studies on the cyclical behavior of BUFs are inconclusive, there is value in studying the cyclical movements of bank regulatory capital buffers in a set of countries that has not been analyzed before. Toward this direction, this is the first empirical study focusing on the cyclical behavior of bank regulatory capital buffers in Africa. Besides examining the cyclical behavior of bank regulatory capital buffers, this paper further investigates the effects of bank revenue diversification, market power and CF on bank regulatory capital buffers.

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Fairweather-Tait, Susan J., and Rachel Collings. "Estimating the Bioavailability Factors Needed for Setting Dietary Reference Values." International Journal for Vitamin and Nutrition Research 80, no. 45 (October 1, 2010): 249–56. http://dx.doi.org/10.1024/0300-9831/a000031.

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Estimated average requirements for micronutrients are central to deriving Dietary Reference Values. These are used for nutrition policies and programs, and also for regulatory and labeling purposes, and are traditionally devised to cover the needs of virtually all individuals in any population group. In order to estimate the average requirement, an appropriate endpoint (biomarker) is selected which describes the relationship between dietary intake and health. However, for some micronutrients, such as zinc, there are no good biomarkers, and for others, such as iron, the intake-status relationship is confounded by variations in absorption. Average requirements for these nutrients are derived using a factorial approach in which physiological needs for tissue growth and maintenance and endogenous losses are estimated, and the total converted to a dietary requirement by taking into account the overall absorption from the diet; i. e. multiplying the requirement by a bioavailability factor. The latter can be determined using algorithms, or estimates from absorption studies, some of which are described in this short review paper.

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Elder, Bruce Robert, and Laurie Swinney. "The good moral character requirement for occupational licensing." Management Research Review 43, no. 6 (December 16, 2019): 717–33. http://dx.doi.org/10.1108/mrr-03-2019-0129.

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Purpose The purpose of this study is to investigate the extent to which a character component is required for occupational licensing by state, industry and occupation. This study also investigates whether the good moral character (GMC) is defined and how GMC is defined in state statutes. Investigating the GMC requirement is important to society at large because character is a vital factor for trust and trust is an essential component to voluntary exchange and free markets. Investigating the GMC requirement is also important to the thousands of rehabilitated individuals who may be denied work in licensed occupations because of past transgressions. Design/methodology/approach The quantitative research data were collected from state licensing statutes. The number of licensed occupations within each of the 50 states that require GMC was tabulated, as well as the number of states that require GMC for licensing by industry group. In addition, an occupation that requires GMC in a high number of states was compared to an occupation that requires GMC in a low number of states within 11 industry groups. Finally, regulatory statutes were searched to determine how good moral character is defined by each of the state licensing boards for the select occupations. Findings This paper reports that the inclusion of a character component within regulatory licensing statutes varies widely by occupation and by state. The number of occupations requiring GMC ranged from 8 to 119 per state. The number of states requiring GMC ranged from 12 to 49 per industry group. Occupations within industry groups that are more frequently licensed are also more likely to require GMC than occupations that are less frequently licensed. Occupations that are more frequently licensed, however, are generally not more likely to define GMC in their regulatory statutes. Only accounting, an occupation that requires GMC in most states, also defines GMC in more states than any of the other select occupations. Research limitations/implications Only state regulatory statutes were searched for definitions of GMC. Definitions could be included in other government documents such as rules or regulations. As these additional sources were not searched, the number of states that define GMC for the select occupations cited in this study may be understated. Originality/value Prior research has included only studies of the GMC requirement relating to the licensing of attorneys and accountants. The current research explores the extent that good moral character is required for licensing across states, industries and select occupations. This research agrees with prior research that GMC, although providing an important foundation for public trust, is typically not well-defined. To counter criticism of the requirement, this paper concludes with a call for the inclusion of a GMC definition within occupational licensing statutes that is “narrowly and precisely construed, avoiding problems of both vagueness and over breadth” (AICPA and NASBA, 2018).

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Xia, Yufei, Zijun Liao, Jun Xu, and Yinguo Li. "FROM CREDIT SCORING TO REGULATORY SCORING: COMPARING CREDIT SCORING MODELS FROM A REGULATORY PERSPECTIVE." Technological and Economic Development of Economy 28, no. 6 (December 15, 2022): 1954–90. http://dx.doi.org/10.3846/tede.2022.17045.

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Conventional credit scoring models evaluated by predictive accuracy or profitability typically serve the financial institutions and can hardly reflect their contribution on financial stability. To remedy this, we develop a novel regulatory scoring framework to quantify and compare the corresponding regulatory capital charge errors of credit scoring models. As an application of RegTech, the proposed framework considers the characteristic of example-dependence and costsensitivity in credit scoring, which is expected to enhance the ability of risk absorption of financial institutions and thus benefit the regulators. Validated on two real-world credit datasets, empirical results reveal that credit scoring models with good predictive accuracy or profitability do not necessarily provide low capital charge requirement error, which further highlights the importance of regulatory scoring framework. The family of gradient boosting decision tree (GBDT) provides significantly better average performance than industry benchmarks and deep multilayer perceptron network, especially when financial stability is the primary focus. To further examine the robustness of the proposed regulatory scoring, sampling techniques, cut-off value modification, and probability calibration are employed within the framework and the main conclusions hold in most cases. Furthermore, the analysis on the interpretability via TreeSHAP algorithm alleviates the concerns on transparency of GBDT-based models, and confirms the important roles of loan characteristics, borrowers’ solvency and creditworthiness as powerful predictors in credit scoring. Finally, the managerial implications for both financial institutions and regulators are discussed.

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Yang, Wei, and Pradip Tapadar. "Role of the Pension Protection Fund in financial risk management of UK defined benefit pension sector: a multi-period economic capital study." Annals of Actuarial Science 9, no. 1 (December 9, 2014): 134–66. http://dx.doi.org/10.1017/s1748499514000256.

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AbstractWith the advent of formal regulatory requirements for rigorous risk-based, or economic, capital quantification for the financial risk management of banking and insurance sectors, regulators and policy-makers are turning their attention to the pension sector, the other integral player in the financial markets. In this paper, we analyse the impact of applying economic capital techniques to defined benefit pension schemes in the United Kingdom. We propose two alternative economic capital quantification approaches, first, for individual defined benefit pension schemes on a stand-alone basis and then for the pension sector as a whole by quantifying economic capital of the UK’s Pension Protection Fund, which takes over eligible schemes with deficit, in the event of sponsor insolvency. We find that economic capital requirements for individual schemes are significantly high. However, we show that sharing risks through the Pension Protection Fund reduces the aggregate economic capital requirement of the entire sector.

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Aballa, A. N., D. U. Ebem, O. A. Eneh, and J. A. Adeniyi. "Relevance of Requirement Engineering In Medical Devices Development." Advances in Multidisciplinary and scientific Research Journal Publication 1 (July 30, 2022): 13–16. http://dx.doi.org/10.22624/aims/rebk2022-p2.

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ABSTRACT Medical device development life cycle requires the strict adherence to the stages outlined by the regulatory bodies to ensure safety of use by patients and clinicians and to ensure high quality products. This chapter tactfully describes how introducing the process of requirement engineering into the medical device development procedures can help in creating high standard medical devices to improve health care administration. Keywords: Medical Devices, Patients, Clinician, Requirement Engineering, Health Care, Safety.

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Xue, Di, Gabriel N. Kaufman, Marieme Dembele, Marianne Beland, Amir H. Massoud, Barbara C. Mindt, Ryan Fiter, et al. "Semaphorin 4C Protects against Allergic Inflammation: Requirement of Regulatory CD138+ Plasma Cells." Journal of Immunology 198, no. 1 (November 23, 2016): 71–81. http://dx.doi.org/10.4049/jimmunol.1600831.

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