Relevant bibliographies by topics / Regulatory requirement

Academic literature on the topic 'Regulatory requirement'

Author: Grafiati
Published: 10 December 2022
Last updated: 28 January 2023

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Contents

Consult the lists of relevant articles, books, theses, conference reports, and other scholarly sources on the topic 'Regulatory requirement.'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Journal articles on the topic "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.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

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.

Full text
Abstract:
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
APA, Harvard, Vancouver, ISO, and other styles
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.

Full text
APA, Harvard, Vancouver, ISO, and other styles
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.

Full text
Abstract:
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.
APA, Harvard, Vancouver, ISO, and other styles
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.

Full text
Abstract:
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.
APA, Harvard, Vancouver, ISO, and other styles
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.

Full text
Abstract:
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.
APA, Harvard, Vancouver, ISO, and other styles
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.

Full text
Abstract:
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.
APA, Harvard, Vancouver, ISO, and other styles
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.

Full text
Abstract:
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.
APA, Harvard, Vancouver, ISO, and other styles
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.

Full text
Abstract:
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.
APA, Harvard, Vancouver, ISO, and other styles
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.

Full text
Abstract:
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.
APA, Harvard, Vancouver, ISO, and other styles
More sources

Dissertations / Theses on the topic "Regulatory requirement"

1

De, Francesco Fabrizio. "A comprehensive analysis of policy diffusion : regulatory impact analysis in EU and OECD member states." Thesis, University of Exeter, 2010. http://hdl.handle.net/10036/3022.

Full text
Abstract:
Among the tools available to enhance the rationality of policy formulation, Regulatory Impact Analysis (RIA) has captured the attention of many scholars for its potential to enhance the accountability and transparency of regulatory governance. Although almost all EU and OECD member states have adopted RIA, only a sub- set of small-n case comparative studies on institutional, political and administrative impact have been conducted. By filling this gap in the literature and proposing the rigorous operationalisation of concepts such as adoption, extent of implementation, and learning, this thesis ascertains the extent of interdependency among governments in their choices concerning an innovation of regulatory governance. Methodologically, the dissertation draws on a multi-method approach, consisting of qualitative analysis to track the process of institutionalisation, as well as event history analysis, based on a dataset covering thirty-eight countries from 1968 to 2006. The empirical findings show that diffusion is a multifaceted process. In the decision to adopt RIA, the role of the OECD in translating, packaging, and promoting such administrative innovation coexists with previous innovations and other administrative variables. Yet the impact of interdependency is marginal in the successive phases of implementation and evaluation. Earliness of adoption is the major predictor of the extent of implementation. There is little evidence of interaction and communication among adopters on the subject of their learning experience. On balance, this regulatory governance innovation is a domain of symbolic and rhetorical meanings that is not adequately supported by administrative capacity.
APA, Harvard, Vancouver, ISO, and other styles
2

Adeegbe, Dennis O. "Allogeneic CD4+CD25+Foxp3+ T Regulatory Cells in Autoimmunity and Transplantation Tolerance: Therapeutic Potential and TCR Repertoire Requirement." Scholarly Repository, 2008. http://scholarlyrepository.miami.edu/oa_dissertations/43.

Full text
Abstract:
CD4+CD25+Foxp3+ T regulatory (Treg) cells are critical in maintaining self tolerance and promoting the acceptance of allogeneic tissue/organ grafts. To be widely applied in clinical settings, there needs to be a readily available source of Treg cells, a requirement that is better met if non-histocompatible donor cells could be utilized in adoptive therapy. Therefore, to investigate the therapeutic potential of fully allogeneic Treg cells to control autoimmune disease or allograft rejection, we utilized IL-2R beta-deficient mice that exhibit rapid lethal autoimmunity due to low production of an ineffective population of Treg cells. We show that adoptive transfer of MHC-mismatched Treg cells into IL-2R beta-/- mice resulted in life-long engraftment of the donor cells, which exhibited skewed reactivity toward host alloantigens, and prevented autoimmunity. When such animals received skin grafts, they exhibited tolerance to those grafts that expressed MHC molecules from which the donor Treg cells were derived. Collectively, these data provide proof-of-principle that effective engraftment by allogeneic Treg cells controls autoimmunity and leads to favorable conditions for long-term acceptance of allografts. Current data indicates that CD4+CD25+Foxp3+ Treg cells exhibit a broad TCR repertoire. However, the relationship between this diversity and capacity to control a similarly diverse population of potentially autoreactive T cells remains to be defined. To investigate this issue, we assessed the TCR repertoire of chimeric donor Treg cells in IL-2R beta-/- mice that were adoptively treated with a diverse polyclonal Treg inoculums. We demonstrate that autoimmune disease was fully prevented by engrafted donor Treg cells in spite of a TCR repertoire that is less diverse than the input cells. However, in settings where the input TCR repertoire is limited by utilizing donor Treg cells that express a single TCR beta chain, control of disease was hampered, correlating with a limited TCR alpha repertoire within the engrafting donor Treg cells. Collectively, these findings suggest that for adoptive therapy, a diverse TCR repertoire of input Treg cell inoculums is an essential requirement for effective control of polyclonal autoreactive T cells but perturbations in the repertoire that results in significant limitation to this diversity may compromise Treg cell efficacy at fully keeping autoaggressive cells in check.
APA, Harvard, Vancouver, ISO, and other styles
3

Khumalo, Jermaine. "The temporal requirement of IL-4Rα signalling in allergic asthma and the role of IL-4Rα-responsive Regulatory T cells in restraining allergic airway inflammation." Doctoral thesis, Faculty of Health Sciences, 2019. https://hdl.handle.net/11427/31728.

Full text
Abstract:
Allergic asthma is a chronic inflammatory airway disease driven predominantly by a TH2 immune response to environmental allergens. The asthma pathology is predominantly elicited by IL-4 and IL-13 signalling via IL-4Rα-signalling which is essential for driving TH2-type immunity to allergens. Interestingly, the failure by regulatory T cells to maintain tolerance during allergic asthma, suggested to be driven by TH2 inflammatory signals, still remains elusive and anti-TH2 therapies with the potential to effectively reduce airway obstruction and inflammation in allergic asthma, have had limited success. Therefore, we aimed to investigate the function of IL-4/IL-13 responsive regulatory T cells in a TH2 rich environment and the temporal requirement of IL-4Rα-signalling in asymptomatic and acute airway disease. Objective 1: We investigated potential therapeutic effects of selective inhibition of this pathway in mice with established allergic airway disease and systemically sensitised mice to prevent the onset of the disease. We used RosacreERT2IL-4Rα-/lox mice, a novel, tamoxifen inducible IL-4Rα knockdown model to investigate the role of IL-4/IL-13 signalling during the effector phase of ovalbumin induced allergic airway disease (AAD) and for the onset of the disease. The deletion of the IL-4Rα had a therapeutic effect on established AAD and prevented the development of ovalbumin induced airway hyperreactivity, goblet cell metaplasia and eosinophilia in allergensensitised mice. We concluded that the abrogation of IL-4Rα signalling after allergic sensitisation would have significant therapeutic benefit for TH2 type allergic asthma. Objective 2: The canonical IL-4Rα-signalling, was investigated on its role on Foxp3+ Tregs in allergic asthma with aims to re-establish tolerance during allergic asthma. We used transgenic Foxp3cre IL-4Rα-/lox mice IL-4Rα-/lox mice to investigate the role of IL-4/IL-13 signalling during the induction or maintenance of tolerance in house dust mite-induced ADD. The depletion of IL-4Ra on Foxp3+ Tregs exacerbated airway hyperreactivity and airway inflammation in allergen- sensitised mice. Interestingly, a reduced induction of Foxp3+ Tregs in peripheral tissue and an accompanying increased IL-33 induced ILC2 driven inflammation in the lung responsible for the exacerbation of TH2 acute disease. Conclusively, the IL-4Rα responsive Foxp3+ T regulatory cells are key in maintaining tolerance in type 2 innate immune driven allergic asthma, therefore the TH2 environment has both an innate immune specific regulative role in local lung tissue and induction of Foxp3+ Tregs in peripheral tissue during AAD. A combined targeting of the pathogenic TH2 environment in anti-TH2 therapy and the augmentation of regulatory T cell function in the local lung tissue is necessary to inhibit both adaptive and innate drivers of TH2 inflammation in allergic disease.
APA, Harvard, Vancouver, ISO, and other styles
4

Cavdarovski, Jove, and Jesper Wallvik. "Kapitaltäckningsregler med valfrihet : en kvalitativ studie om bankers frihet att välja beräkningsmetod för kapitalkravet." Thesis, Högskolan Kristianstad, Sektionen för hälsa och samhälle, 2013. http://urn.kb.se/resolve?urn=urn:nbn:se:hkr:diva-10875.

Full text
Abstract:
Purpose: The purpose of this study is to increase the understanding of how a bank’s features and internal factors have affected its choice of method in calculating the capital requirement. Theoretical and Empirical Method: The research strategy of this study has been of a qualitative nature with a deductive approach. The choice of method was depth interviews with respondents from a targeted sample of Swedish banks. These respondents were chosen based on the knowledge they possess as key employees in the capital requirement process and their involvement in choosing their banks’ method for calculating the capital requirement. The interviews were semi-structured, with open questions that allowed a dialogue with the respondents in which they could express their opinions and knowledge regarding the factors affecting their banks’ choice of method. Theoretical Approach: The study is based on the new institutional economics theory of how institutions affect organizational behavior. It’s also based on earlier research within the regulation Basel II by, among others, Hakenes and Schabel (2011), Rime (2005) and Wahlström (2009). Conclusions: The results of this study show that banks have identified different factors that affect their choice of calculation method for the capital requirement. The choice the banks are facing is to keep the standardized method, develop an advanced internal based method, create partnerships with other banks or focus on alternative clientele portfolios. The two factors that were considered to be have the greatest significant for the choice of calculation method were resources associated with the implementation of the IRB approach models and how the banks’ clientele portfolio was designed. How these were distributed and to what extent they influenced the choice was highly individual for the chosen banks.
Syfte: Syftet med den här studien är att öka förståelsen om hur en banks förutsättningar och interna faktorer har påverkat dess val av beräkningsmetod för kapitalkravet. Teoretisk och empirisk metod: Forskningsstrategin för studien har varit av den kvalitativa typen med en deduktiv ansats. Valet av metod var djupintervjuer med respondenter från ett målinriktat urval av svenska banker. Respondenterna valdes utifrån de kunskaper som de besitter genom sin position på respektive bank, där deras deltagande i metodvalsprocessen påverkade valet av beräkningsmetod. Intervjuerna var av typen semistrukturerade, med öppna intervjufrågor för att få till en dialog med respondenterna och ta del av deras åsikter och kunskaper gällande de olika faktorerna till metodvalet. Teoretisk referensram: Studien utgick från den nyinstitutionella teorin, om hur institutioner påverkar organisationers beteenden. Den har baserats på tidigare forskning inom regelverket Basel II av bland annat Hakenes och Schnabel (2011), Rime (2005) samt Wahlström (2009). Slutsats: Resultatet av denna studie visar på att bankerna har identifierat olika faktorer som påverkar valet av beräkningsmetod för kapitalkravet. Valet som bankerna står inför är att behålla Schablonmetoden, utveckla en IRK-metod, skapa samarbeten med andra banker eller fokusera på alternativa klientelportföljer. De två faktorer som ansågs ha störst signifikans för valet av beräkningsmetod var resurserna som förknippades med implementeringen av modellerna i IRKmetoden och hur bankens klientelportfölj var utformad. Hur dessa var fördelade och i vilken grad de påverkade valet var högst individuellt för de utvalda bankerna.
APA, Harvard, Vancouver, ISO, and other styles
5

Brolin, Sandra. "Global Regulatory Requirements for Medical Devices." Thesis, Mälardalen University, School of Sustainable Development of Society and Technology, 2008. http://urn.kb.se/resolve?urn=urn:nbn:se:mdh:diva-700.

Full text
Abstract:

Medical devices are becoming more important in the health care sector. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. This thesis examines the regulatory requirements for medical devices in Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan and compares them with the requirements in the European Union.

The conclusion of this thesis is that most countries have similar requirements for registration of medical devices and are striving to harmonize with the GHTF guidelines. A company goes far by following the requirements in EU, USA or the GHTF guidelines.

APA, Harvard, Vancouver, ISO, and other styles
6

Vojkůvka, Adam. "Dopady nových regulatorních požadavků na tržní riziko." Master's thesis, Vysoká škola ekonomická v Praze, 2017. http://www.nusl.cz/ntk/nusl-360519.

Full text
Abstract:
The aim of this master thesis is analyze the impact of new regulatory requirements for market risk in terms of internal approach of the selected portfolio. The first part deals with the definition and calculation methods of risk measures Value at Risk and Expected Shortfall. Furthermore, this part is dedicated to model backtesting and determination of the stress period. The second part describes the development of Basel I-III regulatory requirements for market risk with a focus on internal approaches. The third part focuses on the calculation and subsequent analysis of current and new regulatory reguirements for market risk using the historical simulation method, variance and covariance method and Monte Carlo simulation.
APA, Harvard, Vancouver, ISO, and other styles
7

Powell, Michael D. "Insights Into the Regulatory Requirements for T Follicular Helper Cell Development." Diss., Virginia Tech, 2019. http://hdl.handle.net/10919/89085.

Full text
Abstract:
During the course of an immune response, CD4+ T helper cells differentiate into a number of subsets including: T helper 1 (TH1), TH2, TH17, and T follicular helper (TFH) populations. The functional diversity of CD4+ T effector cells results in a coordinated, pathogen-specific immune response. For example, the production of IFNγ by TH1 cells is vital for the clearance of intracellular pathogens, while TFH cell engagement with cognate B cells is required for germinal center (GC) formation and the generation of pathogen- and vaccine- induced antibody production. The development of CD4+ subsets is contingent on extracellular signals, in the form of cytokines, and downstream transcriptional networks responsible for promoting the unique gene expression profile for each subset while simultaneously suppressing alternative cell fates. However, the exact composition of, and stage-specific requirements for, these environmental cytokines and transcription factor networks in the governance of TFH cell differentiation remain incompletely understood. The work in this dissertation seeks to understand how cell-extrinsic cytokine signals and cell-intrinsic transcription factor activities are integrated to properly regulate TFH cell development. Here, we demonstrate that in response to decreased IL-2 and constant IL-12 signaling, T helper 1 (TH1) cells upregulate a TFH-like phenotype, including expression of the TFH lineage defining transcription factor Bcl-6. Intriguingly, our work established that signals from IL-12 were required for both the differentiation and function of this TFH-like population. Mechanistically, IL-12 signals are propagated through both STAT3 and STAT4, leading to the upregulation of the TFH associated genes Bcl6, Il21, and Icos, correlating with increased B cell helper activity. Conversely, exposure of these TFH-like cells to IL-7 results in the STAT5-dependent repression of Bcl-6 and subsequent inhibition of the TFH phenotype. Finally, we describe a novel regulatory mechanism wherein STAT3 and the Ikaros zinc finger transcription factors Ikaros and Aiolos cooperate to regulate Bcl-6 expression in these TFH-like cells. Collectively, the work in this dissertation significantly advances our understanding of the regulatory mechanisms that govern TFH cell differentiation, setting the basis for the rational design of novel immunotherapeutic strategies and increasingly effective vaccines.
Ph. D.
Specialized cells called T helper cells serve as a critical interface between the innate (first line of defense) and adaptive (specialized and long-term) immune systems. During the course of an infection, T helper cells are responsible for orchestrating the immune-mediated elimination of invading viruses, bacteria, and parasites. This wide breadth of functionality is achieved through the formation of distinct T helper subsets including T helper 1 (TH1), TH2, TH17, and T follicular helper (TFH) populations. Individual subsets have distinct developmental requirements and have unique functions within the immune system. For example, TFH cells are required for the production of effective antibodies that recognize invading pathogens, leading to their subsequent elimination. This naturally occurring process is the basis for a number of modern medical therapies including vaccination. Conversely, aberrant generation of antibodies that recognize host tissues can result in the onset of various autoimmune diseases including lupus, multiple sclerosis, and crohn’s disease. Due to the importance of TFH cells to human health, there is intense interest in understanding how these cells are formed. It is recognized that the generation of these therapeutically important immune cells is mediated by numerous cell-extrinsic andintrinsic influences, including proteins in their cellular environment called cytokines, and important proteins inside of the cell called transcription factors. However, as this is a complicated and multi-step process, many questions remain regarding the identity of these cytokines and transcription factors. The work in this dissertation seeks to understand how cellextrinsic cytokine signals and cell-intrinsic transcription factor activities are integrated to properly regulate TFH cell development. Collectively, this body of work significantly advances our understanding of the regulatory mechanisms that govern TFH cell differentiation, setting the basis for the rational design of novel immunotherapeutic strategies and increasingly effective vaccines.
APA, Harvard, Vancouver, ISO, and other styles
8

Sullivan, Mark. "Pollution control upgrade of a hazardous waste incinerator to comply with regulatory requirements." Thesis, This resource online, 1995. http://scholar.lib.vt.edu/theses/available/etd-02132009-170926/.

Full text
APA, Harvard, Vancouver, ISO, and other styles
9

Uhl, Juli D. "Hox Specificity: Constrained vs. Flexible Requirements for the PBC and MEIS Cofactors." University of Cincinnati / OhioLINK, 2014. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1397234792.

Full text
APA, Harvard, Vancouver, ISO, and other styles
10

Malpass, Katy H. "Regulatory T cells : molecular requirements for their selection and therapeutic use in autoimmune disease." Thesis, University of Edinburgh, 2009. http://hdl.handle.net/1842/4636.

Full text
Abstract:
Regulatory T cells (Tregs), expressing the transcription factor Foxp3, form a key component of peripheral immune tolerance, guarding against auto-aggressive immune responses. Multiple Sclerosis is an inflammatory and demyelinating disease of the central nervous system (CNS) which is largely believed to be mediated by immune components reacting to the self myelin antigens that insulate the nerve fibres. Recent investigations have reported that regulatory T cells are dysfunctional in MS patients; therefore enhancing the regulatory T cell responses in MS is an attractive therapeutic target. Using the mouse model of MS, experimental autoimmune encephalomyelitis (EAE) we have attempted to develop disease-relevant Treg-based therapies to prevent disease induction. This required an understanding of the antigenic-reactivity of Tregs during disease. Results described in this thesis show that a proportion of Tregs in the draining lymph nodes and CNS were reactive to the disease initiating antigen(s) and could suppress in vitro responses of naïve T cells bearing transgenic T cell receptors, recognising the same antigen. Adoptive transfer of antigen-reactive Tregs suppressed disease induced with the same antigen, but also reduced disease induced with a distinct myelin antigen. Peptide-based tolerance using a high affinity MHC binding peptide analogue expanded and maintained antigen-reactive T cells which were tolerant to antigenic restimulation, although these cells did not express Foxp3. Peptide-treated mice showed reduced incidence of disease relapses during EAE induced against a distinct myelin antigen. Thus, while EAE and MS will involve a polyclonal effector T cell response to many antigens, therapeutic targeting of Tregs reactive against one CNS component may be sufficient to reduce disease. Endogenous expression of myelin autoantigen did not grossly alter the response of antigenreactive Tregs in the periphery. However, expression of endogenously derived viral superantigen enhanced the proportion of superantigen-reactive Foxp3+ Tregs in the periphery. This observation was extended using exogenous superantigen, suggesting that prolonged exposure to low dose (super)antigen tips the balance of the immune system in favour of regulation. This has implications for the ability to successfully fight infection, as well as for the limitation of autoaggressive responses and may contribute to the understanding of the hygiene hypothesis.
APA, Harvard, Vancouver, ISO, and other styles
More sources

Books on the topic "Regulatory requirement"

1

Office, General Accounting. Regulatory reform: Compliance guide requirement has had little effect on agency practices : report to the ranking minority member, Committee on Small Business and Entrepreneurship U.S. Senate. Washington, DC: The Office, 2001.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
2

Torp, Jeffrey. Regulatory compliance audit program: Checklists & related regulatory requirements. Austin, Tex. (7000 West William Cannon Dr., Suite 2230, Austin 78735): AlexInformation, 2002.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
3

Torp, Jeffrey. Information security: Satisfying regulatory requirements. Austin, Tex. (2801 Via Fortuna, Ste. 600, Austin, 78746): AlexInformation, 2003.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
4

Majumdar, Somendu B. Regulatory requirements for hazardous materials. New York: McGraw-Hill, 1993.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
5

Torp, Jeffrey. Regulatory compliance audit program for credit unions: Checklists & related regulatory requirements. 2nd ed. Austin, Tex. (7000 West William Cannon Dr., Suite 2300, Austin 78735): AlexInformation, 2002.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
6

Torp, Jeffrey. Regulatory compliance audit program for credit unions: Checklists & related regulatory requirements. Austin, Tex. (7000 West William Cannon Dr., Suite 2300, Austin 78735): AlexInformation, 2001.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
7

Torp, Jeffrey. Regulatory compliance audit program for credit unions: Checklists & related regulatory requirements. 2nd ed. Austin, Tex. (7000 West William Cannon Dr., Suite 2300, Austin 78735): AlexInformation, 2003.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
8

Kshirsagar, Nilima. Regulatory requirements for drug development and clinical research. New Delhi: Indian Council of Medical Research, 2013.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
9

Kanfer, Isadore. Generic drug product development: International regulatory requirements for bioequivalence. New York: Informa Healthcare, 2010.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
10

Mancuso, John H. Reporting to bank regulators: Requirements and forms manual. Boston, Mass: Warren, Gorham & Lamont, 1990.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
More sources

Book chapters on the topic "Regulatory requirement"

1

Tian, Weidong. "Regulatory Capital Requirement in Basel III." In Commercial Banking Risk Management, 3–34. New York: Palgrave Macmillan US, 2016. http://dx.doi.org/10.1057/978-1-137-59442-6_1.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Suzuki, Yasuhiro. "How Should We Move Forward? New Regulatory Requirement and Frameworks." In Active Faults and Nuclear Regulation, 53–60. Singapore: Springer Singapore, 2020. http://dx.doi.org/10.1007/978-981-15-0765-6_5.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Chateau, Jean Pierre, and Daniel Dufresne. "Banks’ Regulatory Capital Requirement: Pricing the Credit Risk of Short-Term Loan Commitments." In Regulierung oder Deregulierung der Finanzmärkte, 243–62. Heidelberg: Physica-Verlag HD, 2002. http://dx.doi.org/10.1007/978-3-642-57492-4_18.

Full text
APA, Harvard, Vancouver, ISO, and other styles
4

Coles, Michael, and Rodney Landrum. "Regulatory Requirements." In Expert SQL Server 2008 Encryption, 231–41. Berkeley, CA: Apress, 2009. http://dx.doi.org/10.1007/978-1-4302-3365-7_11.

Full text
APA, Harvard, Vancouver, ISO, and other styles
5

Young, Jeffrey S. "Regulatory Requirements." In Trauma Centers, 139–49. Cham: Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-34607-2_12.

Full text
APA, Harvard, Vancouver, ISO, and other styles
6

Chan, Chung Chow, Sultan Ghani, Iain Simpson, and James Blakemore. "Challenges to Quality and Regulatory Requirement in the United States-Drugs, Medical Device, and Cell Therapy." In Therapeutic Delivery Solutions, 1–34. Hoboken, NJ: John Wiley & Sons, Inc., 2014. http://dx.doi.org/10.1002/9781118903681.ch1.

Full text
APA, Harvard, Vancouver, ISO, and other styles
7

Leighton, F., S. Nicovani, U. Soto, C. Skorin, and C. Necochea. "Peroxisomal Properties with Potential Regulatory Implications: Selective ATP Requirement for Fatty Acid Oxidation and Membrane Protein Phosphorylation." In Proceedings in Life Sciences, 177–88. Berlin, Heidelberg: Springer Berlin Heidelberg, 1987. http://dx.doi.org/10.1007/978-3-642-71325-5_16.

Full text
APA, Harvard, Vancouver, ISO, and other styles
8

Teather, F. W. "International Regulatory Requirements." In Early Phase Drug Evaluation in Man, 83–88. London: Macmillan Education UK, 1990. http://dx.doi.org/10.1007/978-1-349-10705-6_6.

Full text
APA, Harvard, Vancouver, ISO, and other styles
9

Cramer, Michael M. "Sanitation Regulatory Requirements." In Food Plant Sanitation, 1–34. 3rd ed. Boca Raton: CRC Press, 2022. http://dx.doi.org/10.1201/9780429294341-1.

Full text
APA, Harvard, Vancouver, ISO, and other styles
10

Werther, Winifred, and Anita M. Loughlin. "Post-Approval Regulatory Requirements." In Principles and Practice of Clinical Trials, 1–28. Cham: Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-319-52677-5_256-1.

Full text
APA, Harvard, Vancouver, ISO, and other styles

Conference papers on the topic "Regulatory requirement"

1

Eckert, Ted. "Strategies for tracking regulatory requirement changes." In 2012 IEEE Symposium on Product Compliance Engineering (ISPCE). IEEE, 2012. http://dx.doi.org/10.1109/ispce.2012.6398286.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Janpitak, Nanta, Chanboon Sathitwiriyawong, and Phatwarat Pipatthanaudomdee. "Information Security Requirement Extraction from Regulatory Documents using GATE/ANNIC." In 2019 7th International Electrical Engineering Congress (iEECON). IEEE, 2019. http://dx.doi.org/10.1109/ieecon45304.2019.8938899.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Hayes, Jan, Lynne Chester, and Dolruedee Kramnaimuang King. "Is Public Safety Impacted by the Multiple Regulatory Regimes for Gas Pipelines and Networks?" In 2018 12th International Pipeline Conference. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/ipc2018-78160.

Full text
Abstract:
Gas pipelines and networks are subject to multiple regulatory governance arrangements. One regime is economic regulation which is designed to ensure fair access to gas markets and emulate the price pressures of competition in a sector dominated by a few companies. Another regime is technical regulation which is designed to ensure pipeline system integrity is sufficient for the purposes of public safety, environmental protection and physical security of supply. As was highlighted in analysis of the San Bruno pipeline failure, these two regulatory regimes have substantially different orientations towards expenditure on things such as maintenance and inspection which ultimately impact public safety. Drawing on more than 50 interviews, document review and case studies of specific price determinations, we have investigated the extent to which these two regulatory regimes as enacted in Australia may conflict, and particularly whether economic regulation influences long-term public safety outcomes. We also draw on a comparison with how similar regulatory requirements are enacted in the United Kingdom (UK). Analysis shows that the overall orientation towards risk varies between the two regimes. The technical regulatory regime is a typical goal-setting style of risk governance with an overarching requirement that ‘reasonably practicable’ measures are put in place to minimize risk to the public. In contrast, the incentive-based economic regulatory regime requires that expenditure should be ‘efficient’ to warrant inclusion in the determination of acceptable charges to customers. How safety is considered within this remains an open question. Best practice in performance-based safety regimes such as those used in the UK and Australia require that regulators adopt an attitude towards companies based on the principle of ‘trust but verify’ as, generally speaking, all parties aim for the common goal of no accidents. Equally, in jurisdictions that favor prescriptive safety requirements such as the United States (US) the common goal remains. In contrast, stakeholders in the economic regulatory regime have significantly diverse interests; companies seek to maximize their individual financial returns and regulators seek to exert downward price pressures. We argue that these differences in the two regulatory regimes are significant for the management of public safety risk and conclude that minimizing risk to the public from a major pipeline failure would be better served by the economic regulatory regime’s separate consideration of safety-related from other expenditure and informed by the technical regulator’s view of safety.
APA, Harvard, Vancouver, ISO, and other styles
4

Lutz, Robert J., and Robert P. Prior. "Comparison of Fukushima Response in the United States and Europe." In 2016 24th International Conference on Nuclear Engineering. American Society of Mechanical Engineers, 2016. http://dx.doi.org/10.1115/icone24-60101.

Full text
Abstract:
The accident at the three reactor units at Fukushima Daiichi showed weaknesses in the plant coping capability for beyond design basis accidents caused by extreme external events. The weaknesses included plant design features, accident management procedures and guidance, and offsite emergency response. As a result, significant changes to plant coping capability have been made to light water reactors worldwide to enhance the coping capabilities for beyond design basis accidents. However, the response in the United States has been significantly different from that in Europe in a number of ways. In the United States, the regulator and the industry convened separate expert panels to review the Fukushima accident and make recommendations for enhancements. On the regulatory side, a series of three Orders were issued and that required the implementation of certain enhancements (Mitigation strategies, hardened vents for certain BWRs, spent fuel pool level indication) to ensure adequate protection for the health and safety of the public. Other enhancements were subject to the “Backfit Rule” which requires that changes to regulatory requirements be shown to be cost beneficial using accepted methodologies. Simultaneously, the industry took independent steps to develop a diverse and flexible coping strategies (known as FLEX) and other enhancements. The focus in the United States was clearly on enhancements to guarantee continued core, containment and spent fuel pool cooling in the event of beyond design basis accidents, particularly those resulting from extreme external events. In Europe, the regulatory agencies ordered the development and completion of “Stress Tests” for each reactor site. These Stress Tests were focused on identifying the capability of the plant and its staff to respond to increasingly severe external events. The Stress Tests not only examined the ability to maintain core, containment and spent fuel pool cooling but also the ability to mitigate the consequences of accidents that progress to core damage (i.e., a severe accident). Regulatory requirements were then issued by the national regulators that addressed the weaknesses identified from the Stress Tests. While many of the enhancements to the plant coping capability were similar to those in the United States, significant hardware enhancements were also required to reduce the consequences of core damage accidents including hydrogen control and containment filtered venting. Finally, most European regulators also include severe accident management guidance (SAMG) as a regulatory requirement. In the United States, SAMG will be maintained as a voluntary industry commitment that is subject to regulatory oversight review.
APA, Harvard, Vancouver, ISO, and other styles
5

Tada, Kenji, Tadao Kanda, Takayuki Sakuma, Masataka Tanimoto, Kazuhide Kitahara, Mikio Kurihara, Yukinori Goto, and Zenichi Ogiso. "Current Endorsement of Consensus Codes for Regulatory Technical Standards in Japan." In 16th International Conference on Nuclear Engineering. ASMEDC, 2008. http://dx.doi.org/10.1115/icone16-48829.

Full text
Abstract:
In Japan, on January 1, 2006, “Ordinance of the Ministry for Establishing Technical Standards of Nuclear Power Generation Systems” (so called Ordinance No.62) was revised. The revised Ordinance No. 62 provides only functional requirements or performance requirement for nuclear power facilities, and detailed specifications — such as the detailed requirement of material and structure for a pressure vessel — are used to endorse consensus codes, like the Codes of the Japan Society of Mechanical Engineers (JSME). To endorse consensus codes, the Nuclear and Industrial Safety Agency (NISA), the regulatory body, and the Japan Nuclear Energy Safety Organization (JNES), a technical support organization, have done technical evaluations on several of the required consensus codes, and these results have been provided in the Regulatory Guide of Ordinance No.62. The activities of technical evaluation of the consensus codes were reported at the ICONE14th. This paper shows their subsequent situation, and the activities of proposing new codes that are not yet in the Societies’ code.
APA, Harvard, Vancouver, ISO, and other styles
6

Naylor, Joe, Eric Lang, and Tennille Benson. "Traceable, Verifiable and Complete Pipeline Records." In 2014 10th International Pipeline Conference. American Society of Mechanical Engineers, 2014. http://dx.doi.org/10.1115/ipc2014-33106.

Full text
Abstract:
Recent U.S. federal regulatory initiatives have focused on the requirement that pipeline operators know their systems and have documented records demonstrating the basis for establishment of MAOP. This has involved the location and cataloging of pipeline records, and verification of the existence of traceable, verifiable and complete pipeline records. This paper provides a review of materials useful for compliance with the recently emphasized records requirements, including historic and recent regulatory requirements along with a concise summary of currently effective regulations. The requirement for traceable, verifiable and complete records is discussed and a proposed elaboration of the concepts is presented. Best practices for records management are outlined, and a methodology is proposed for quality ranking of located documents. Finally, common records problems are discussed and some possible technical approaches are suggested to address typical records issues.
APA, Harvard, Vancouver, ISO, and other styles
7

Jinquan, Yan, Chen Song, Tian Lin, and Wang Minglu. "Requirement and Discussion of Design Extension Conditions." In 2017 25th International Conference on Nuclear Engineering. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/icone25-67529.

Full text
Abstract:
Nuclear safety especially severe accidents risks are of great concerns of nuclear power plant. Design consideration of severe accident prevention and mitigation is generally required by various nuclear safety authorities worldwide. However, those requirements related to severe accidents consideration are somewhat different from country to country. Recently, the International Atomic Energy Agency (IAEA) updated and published a safety code on Specific Safety Requirement of Nuclear Power Plant Safety: Design (SSR-2/1). Meanwhile, the Chinese National Nuclear Safety Administration (NNSA) also revised and updated the safety code on Requirement of Nuclear Power Plant Safety in Design (HAF102). In these two codes, both IAEA and NNSA established some new requirements, among which two are of great concern. One is Design Extension Conditions (DEC) for consideration of those conditions traditionally called Beyond Design Basis Accidents (BDBA) in design of nuclear power plant, another is requirement of practically eliminating large release of radionuclide. These two new requirements are internally related, somewhat different and more restrict from those related to severe accident requirements set forth by Nuclear Regulatory Committee of United States (USNRC). Up to date, there are no specific guidelines about engineering implementation of those new safety codes. This paper present an overview of those requirements from IAEA, WENRA, NRC and China NNSA, followed by discussion of engineering approach for the implementation of the DEC requirement set forth by safety authorities.
APA, Harvard, Vancouver, ISO, and other styles
8

Massoudi, Nasser. "Suggested Guide for Geotechnical Sampling and Testing of Backfill and Borrow for Safety Related Nuclear Structures." In 2016 24th International Conference on Nuclear Engineering. American Society of Mechanical Engineers, 2016. http://dx.doi.org/10.1115/icone24-60004.

Full text
Abstract:
For licensing, design, and construction of nuclear facilities, the investigation of engineering properties of soil borrow and backfill materials is a regulatory requirement, for they impact the performance of these facilities. For instance, the U.S. Nuclear Regulatory Commission (NRC) specifically requires that all applications for nuclear power plants address the source, quantity, static, and dynamic engineering properties of borrow and backfill materials. However, in the nuclear industry, a clear road map does not exist for meeting these requirements. As such, planning, investigation, and/or processes that are needed to address these regulatory requirements become a challenge to applicants. The absence of such a road map can also result in incomplete or unnecessary investigations, licensing cycles, and/or delays. This paper outlines a recommended practice, including steps to design a geotechnical sampling and laboratory investigation program toward addressing these regulatory requirements, with nuclear quality assurance and licensing requirements in perspective. While the steps in this paper may serve as useful guides, requirements vary from project to project; therefore, all efforts should be on developing an investigation program that is project specific in order to meet the actual project objectives. Additionally, this paper provides guidance on presenting the investigation results in regulatory documents.
APA, Harvard, Vancouver, ISO, and other styles
9

Azarm, Mohamed A., and Richard J. Travis. "Fire Safety in Nuclear Power Plants: A Risk-Informed and Performance-Based Approach." In ASME 1999 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 1999. http://dx.doi.org/10.1115/imece1999-1154.

Full text
Abstract:
Abstract The consideration of risk in regulatory decision-making has long been a part of NRC’s policy and practice. Initially, these considerations were qualitative and were based on risk insights. The early regulations relied on good practices, past insights, and accepted standards. As a result, most NRC regulations were prescriptive and were applied uniformly to all areas within the regulatory scope. Risk technology is changing regulations by prioritizing the areas within regulatory scope based on risk, thereby focusing on the risk-important areas. Performance technology, on the other hand, is changing the regulations by allowing requirements to be adjusted based on the specific performance expected and manifested, rather than a prior prescriptive requirement. Consistent with the objectives of risk-informed and performance-based regulatory requirements, BNL evaluated the feasibility of applying risk- and performance-technologies to modifying NRC’s current regulations on fire protection for nuclear power plants.(1) This feasibility study entailed several case studies (trial applications). This paper describes the results of two of them. Besides the case studies, the paper discusses an overall evaluation of methodologies for fire-risk analysis to support the risk-informed regulation. It identifies some current shortcomings and proposes some near-term solutions.
APA, Harvard, Vancouver, ISO, and other styles
10

Ashar, Hans, Eugene Imbro, and David Terao. "Integrated Leak Rate Testing of Containments: A Regulatory Perspective." In ASME 2002 Pressure Vessels and Piping Conference. ASMEDC, 2002. http://dx.doi.org/10.1115/pvp2002-1520.

Full text
Abstract:
Appendix J of 10 CFR 50, “Primary Reactor Containment Leakage Testing for Water-Cooled Power Reactors,” sets the testing requirements for preoperational and periodic verification of the leak-tight integrity of the primary reactor containment, including systems and components which penetrate containment of light water-cooled power reactors, and establishes the acceptance criteria for such tests. The purposes of the tests are to assure that leakage through the primary reactor containment and systems and components penetrating primary containment would not exceed allowable leakage rate values as specified in the plants’ technical specifications. The current Appendix J requirements provide two options for performing the tests. Option A (fully deterministic) requires that after the preoperational leakage rate tests, a set of three integrated leak rate tests (ILRT — termed as Type A tests) shall be performed, at approximately equal intervals during each 10-year service period. Option B does not provide a quantitative requirement for scheduling the periodic Type A tests. However, NEI 94-01, “Industry Guideline for Implementing Performance-Based Option of 10 CFR Part 50, Appendix J,” and NRC Regulatory Guide (RG). The containment is a vital engineering safety feature of a nuclear power plant. It encloses the entire reactor and reactor coolant system and serves as a final barrier against the release of radioactive fission products to the environment under various accident conditions. Containment design is based on pressure and temperature loadings associated with a loss-of-coolant-accident resulting from a double-ended rupture of the largest pipe in the reactor coolant system. Recently, it has been reported that in certain 1.163, “Performance-Based Containment Leak Test Program,” provide guidelines for determining the frequencies of preoperational and periodic leak rate tests using a performance based approach. The Option B requirements and NEI 94-01 guidance are based on NUREG-1493, “Performance Based Containment Leak-Test Program.” Based on the information provided by the operating data and their risk significance, the study calculated the change in risk (in person-rem) to public for the 15 alternatives considered in the study. However, recognizing the non-sensitivity of risk to change in Type A leak rate testing frequencies, as depicted in NUREG-1493, a number of licensees are proposing changes to their Type A test frequencies using NRC risk-informed guidance in RG 1.174, “An Approach for Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis.” The paper discusses certain key deterministic aspects of the risk-informed decision for the plant-specific changes in the ILRT frequencies.
APA, Harvard, Vancouver, ISO, and other styles

Reports on the topic "Regulatory requirement"

1

Andrade, Juan E., Abu Noman Mohammed Atahar Ali, Reajul Chowdhury, Benjamin Crost, Vivian Hoffmann, Shoumi Mustafa, and Nabila Afrin Shaima. Rice fortification in Bangladesh: Technical feasibility and regulatory requirement for introducing rice fortification in public modern storage/distribution of fortified rice through PFDS channels. Washington, DC: International Food Policy Research Institute, 2021. http://dx.doi.org/10.2499/p15738coll2.134540.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Gollenbeek, Luuk, Phillip Ehlert, and Fridtjof Buisonjé. Perspectives of Ecochar in Europe : Uses and regulatory requirements. Wageningen: Wageningen Livestock Research, 2018. http://dx.doi.org/10.18174/452704.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Puder, Markus G., Bill Bryson, and John A. Veil. Compendium of Regulatory Requirements Governing Underground Injection of Drilling Wastes. Office of Scientific and Technical Information (OSTI), March 2003. http://dx.doi.org/10.2172/808473.

Full text
APA, Harvard, Vancouver, ISO, and other styles
4

Puder, M. G., B. Bryson, and J. A. Veil. Compendium of regulatory requirements governing underground injection of drilling waste. Office of Scientific and Technical Information (OSTI), November 2002. http://dx.doi.org/10.2172/819454.

Full text
APA, Harvard, Vancouver, ISO, and other styles
5

Keller, J. F., M. G. Woodruff, A. J. Schmidt, P. L. Hendrickson, and K. B. Selby. Regulatory requirements important to Hanford single-shell tank waste management decisions. Office of Scientific and Technical Information (OSTI), June 1989. http://dx.doi.org/10.2172/6075363.

Full text
APA, Harvard, Vancouver, ISO, and other styles
6

Romano, Joseph, Martha Brady, and Judy Manning. Nonclinical development needs and regulatory requirements for multipurpose prevention technologies: A primer. Population Council, 2012. http://dx.doi.org/10.31899/hiv1.1015.

Full text
APA, Harvard, Vancouver, ISO, and other styles
7

Petti, D. A., and J. C. Haire. Requirements for US regulatory approval of the International Thermonuclear Experimental Reactor (ITER). Office of Scientific and Technical Information (OSTI), December 1993. http://dx.doi.org/10.2172/10146241.

Full text
APA, Harvard, Vancouver, ISO, and other styles
8

Carder, Paula, Janet O'Keefe, Christine O'Keefe, Erin White, and Joshua Wiener. State Regulatory Provisions for Residential Care Settings: An Overview of Staffing Requirements. RTI Press, July 2016. http://dx.doi.org/10.3768/rtipress.2016.op.0030.1607.

Full text
APA, Harvard, Vancouver, ISO, and other styles
9

Mulkey, C. H. Data quality objectives for regulatory requirements for wastewater effluents sampling and analysis. Office of Scientific and Technical Information (OSTI), March 1996. http://dx.doi.org/10.2172/481428.

Full text
APA, Harvard, Vancouver, ISO, and other styles
10

MULKEY, C. H. Data Quality Objectives for Regulatory Requirements for Dangerous Waste Sampling and Analysis. Office of Scientific and Technical Information (OSTI), July 1999. http://dx.doi.org/10.2172/797557.

Full text
APA, Harvard, Vancouver, ISO, and other styles
You might also be interested in the extended bibliographies on the topic 'Regulatory requirement' for particular source types:
Journal articles Dissertations / Theses Books
We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!

To the bibliography