Relevant bibliographies by topics / Regulatory Affair

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Regulatory Affair'

Author: Grafiati
Published: 21 February 2023

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Journal articles on the topic "Regulatory Affair"

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Makwana, Rajdeep G., Kuldeep V. Desai, Vaibhav Kikani, and Maulikkumar D. Vaja. "Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe." International Journal of Drug Regulatory Affairs 9, no. 2 (June 16, 2021): 52–65. http://dx.doi.org/10.22270/ijdra.v9i2.470.

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Drug Regulatory Affairs (DRA) is a vital unit in a pharmaceutical company. It is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safety and efficacy in pharmaceuticals, veterinary medicines, medical devices, cosmetics and complementary medicines, healthcare products to individuals around the world. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. As India is growing very rapidly in pharmaceutical sector, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Today 35 member countries along with 11 candidate countries and 4 international agencies have joined together to create the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to promote a globally accepted GMP. Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for marketing authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO).
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Vaibhav Subhash Janjal, Snehal Ramdas Dhamodkar, Yogesh Pralhad Jadhao, Sima Baburao Manmode, Anil Keshav Pawar, and Harshada Ravindra Khandelwal. "Recent drug regulatory affair and CTD module progress review for submission of pharmaceuticals product." GSC Biological and Pharmaceutical Sciences 16, no. 3 (September 30, 2021): 200–221. http://dx.doi.org/10.30574/gscbps.2021.16.3.0279.

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Regulatory Affairs (RA), also known as government affairs, is a relatively new profession that arose from governments' desire to protect public health by regulating the safety and efficacy of products such as pharmaceuticals, medical devices, pesticides, veterinary medicines, cosmetics, agrochemicals, and complementary medicines. Pharmaceutical regulatory affairs is concerned with the registration of pharmaceutical goods. All regulatory elements and guidelines connected to product filing are summarized in this evaluation. This study covers the whole CTD and eCTD submission process, as well as the modules that go with it. It also focuses on the key regulatory bodies across the world. Various roles of DRA departments, drug regulatory affairs professionals, the importance of drug affairs in pharmacy curriculum, emerging trends affecting regulatory strategy, regulatory affairs in product management, clinical trials, R&D and the drug approval process in the US, EU, and ROW market trends are discussed.
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Paricharak, Sukanya, Atul Baravkar, Apeksha Masal, Sushma Chougule, Pooja Deshmane, and Sachin Kulkarni. "A comprehensive synopsis on cognizance of Regulatory Affairs in different sectors of Pharmacy." International Journal of Drug Regulatory Affairs 9, no. 4 (December 26, 2021): 20–32. http://dx.doi.org/10.22270/ijdra.v9i4.495.

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A pharmaceutical drug regulatory Affairs is mainly involved in registration process parameters of different pharmaceutical products and new drug application. Regulatory affairs (RA) professionals play vital roles in a pharmaceutical field as, it is related to healthcare products. It provides strategic, operational direction and support for working within regulations to expedite the development of pharmaceutical, biological and medical devices. Also, it is principally concern with safety and efficacy, low risk/high benefit and quality assessment of healthcare drug products throughout the world. Regulatory system of each and every country has different regulatory agencies which govern certification and good manufacturing practices. Regulatory Affairs also has a very specific importance within the formulation and marketing of drug product in pharmaceutical industries. Current abstract reports for the first time and emphasizes on studies concerning awareness and knowledge testing in regulatory affair field by the various pharma professionals. This is completely certified online survey of quiz questionnaire based on important concepts in RA and circulated via google form to different social medias to more than 1000 pharma professionals (Academics, Students, Industrials area). The systematic analysis of received responses reveals awareness and knowledge of the participants about RA in selected pharma professionals. It shows that, participants form industrial area having more knowledge than academics and students. This survey comes out with conclusion that, there is more need to raise RA information sources by the inclusion of this subject in syllabus for academics via various courses to fulfill more RA professional demands in future.
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Chong, Han Chung, Chek Kun Tan, Royston-Luke Huang, and Nguan Soon Tan. "Matricellular Proteins: A Sticky Affair with Cancers." Journal of Oncology 2012 (2012): 1–17. http://dx.doi.org/10.1155/2012/351089.

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The multistep process of metastasis is a major hallmark of cancer progression involving the cointeraction and coevolution of the tumor and its microenvironment. In the tumor microenvironment, tumor cells and the surrounding stromal cells aberrantly secrete matricellular proteins, which are a family of nonstructural proteins in the extracellular matrix (ECM) that exert regulatory roles via a variety of molecular mechanisms. Matricellular proteins provide signals that support tumorigenic activities characteristic of the metastastic cascade such as epithelial-to-mesenchymal (EMT) transition, angiogenesis, tumor cell motility, proliferation, invasion, evasion from immune surveillance, and survival of anoikis. Herein, we review the current understanding of the following matricellular proteins and highlight their pivotal and multifacted roles in metastatic progression: angiopoietin-like protein 4 (ANGPTL4), CCN family members cysteine-rich angiogenic inducer 61 (Cyr61/CCN1) and CCN6, osteopontin (OPN), secreted protein acidic and rich in cysteine (SPARC), tenascin C (TNC), and thrombospondin-1 and -2 (TSP1, TSP2). Insights into the signaling mechanisms resulting from the interaction of these matricellular proteins and their respective molecular partner(s), as well as their subsequent contribution to tumor metastasis, are discussed. In addition, emerging evidences of their promising potential as therapeutic options and/or targets in the treatment of cancer are also highlighted.
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Marietta, Morgan. "The Historical Continuum of Financial Illusion." American Economist 40, no. 1 (March 1996): 79–91. http://dx.doi.org/10.1177/056943459604000110.

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Can a clever financier outrun a diligent regulatory system? Are these recurrent excesses controllable, or are they an inevitable feature of economic life? The paper examines a representative history of financial illusions, specifically John Law's 18th century Mississippi Bubble, the original 1920s Ponzi scheme, the Investors Overseas Services (IOS) affair of the 1970s, and the Bank of Credit and Commerce International (BCCI) affair, illustrating the growth over time in the size and complexity of such institutions as well as some of their animating characteristics. If a certain level of entrepreneurial experimentation (deviltry) is a necessary and permanent fixture of the economy, and if we cannot successfully determine between the desirable and the undesirable before outcomes are known, we are faced with continuing growth along the continuum of financial illusion.
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Petrova, Iryna. "UNIFICATION OF RECORDS MANAGEMENT IN THE INFORMATION SPECIALIST PROFESSIONAL CULTURE." Bulletin of Mariupol State University. Series: Philosophy, culture studies, sociology 10, no. 20 (2020): 78–86. http://dx.doi.org/10.34079/2226-2830-2020-10-20-78-86.

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The article defines the relevance of the formation of professional culture of the information specialist, caused by the approval of the specialty «Information, library and archival affairs». This event provoked a discussion on the specification of the content of the information affair, as well as an understanding of the need to create a modern, complex and universal model of an information specialist. Based on the analysis of higher education standards in the specialty 029 Information, library and archival affairs of bachelor’s and master’s level of higher education, scientific publications devoted to the training of higher education applicants in this specialty and the professional culture of records managers, professional competencies that should be appropriate in the professional (information specialist) were established. The features of understanding the concept “unification of records management” were considered, its content, ability to implement and use promote the formation of professional culture of the information specialist within the specialty “Information, library and archival affairs”. The current state of the regulatory framework for the organization of documentation of management information and organizing work with official documents in today’s Ukraine as a factor that determines the level of unification of records management and influences the formation of the professional culture of the information specialist were analyzed. Regulation of office work based on rules specified in regulatory legal acts promotes compliance to the principles of quality, efficiency, lack of duplication of operations in working with official documents that directly affects the efficiency of modern Ukrainian authorities, institutions, enterprises, organizations
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PHILLIPS, CHARLES D., ANNE-MARIE KIMBELL, CATHERINE HAWES, JANET WELLS, JEAN BADALAMENTI, and MARY JANE KOREN. "It's a family affair: consumer advocacy for nursing-home residents in the United States." Ageing and Society 28, no. 1 (January 2008): 67–84. http://dx.doi.org/10.1017/s0144686x07006435.

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ABSTRACTNursing homes in the United States have for over 40-years been riddled with evidence of poor performance. To combat problems in this industry, state and federal governments developed an elaborate monitoring and regulatory structure. At the same time, an important citizens' movement involving nursing-home consumer advocacy groups (CAGs) came to life. This paper presents the results of a postal survey of 47 active nursing-home consumer advocacy groups. They indicate that the majority of these organisations were started by an individual dissatisfied with the care provided to a family member. The political arena in which these organisations were most active was State legislatures. Though they varied considerably, the average CAG operated on a thin financial margin, largely supported by member contributions and donations. These organisations defined their success in terms of their ability to generate policy changes at the State level. Unfortunately, as they pursued these changes, they often failed to develop the organisational infrastructure necessary to assure the CAGs' continued operation. When CAGs ceased operations, it was in most cases the loss of the organisation's original leader or the cumulative effects of the constant struggle to maintain adequate financial resources.
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Perlman, Rebecca L. "The Domestic Impact of International Standards." International Studies Quarterly 64, no. 3 (May 12, 2020): 600–608. http://dx.doi.org/10.1093/isq/sqaa025.

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Abstract Regulation is no longer purely a domestic affair. International standards now exist across a broad range of regulatory arenas, touching on issues that may be central to domestic values, such as the regulation of health, safety, and the environment. Although a number of studies have looked at the domestic impact of globalization more generally, few scholars have evaluated the effects of international standards, specifically. This paper investigates that issue, with an empirical focus on agrochemicals. Using original data on changes to US agrochemical regulations between 1996 and 2015, I evaluate whether and how domestic rules have changed in response to international standards. Contrary to common fears, I find little evidence that international standards primarily act as a ceiling, thereby undermining domestic regulations. Instead, international standards seem to serve as focal points, pulling nations toward leniency as well as toward stringency. These findings not only contribute to the broader literature on the domestic effects of globalization, but they also allay concerns that international standards could act as a regulatory cap, encouraging nations to sacrifice caution for economic gain.
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., Afriyanni. "Permasalahan Pelaksanaan Pelayanan Administrasi Terpadu Kecamatan (Paten) Di Kota Padang." Jurnal Pembangunan Nagari 3, no. 1 (June 30, 2018): 97. http://dx.doi.org/10.30559/jpn.v3i1.76.

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PATEN is a new public management centered in the sub-district to improve the quality and bring the service closer to the community. Since Regulatory of minister Affair number 4 in 2010 was declared. The Implementation of PATEN in Indonesia nowdays reach 15 percent. This research aims to identify the problem of impelementation PATEN in Pilot district projects in Padang in order to provide recommendation for PATEN implementation. This study used descriptive qualitative research through observation, documentation and interview in collecting data. The result showed that there are a number of obstacles in the implementation of PATEN namely the delegation of authority, procedures, human resources, limited facilities and infrastructure. For That, it is amust for the Local Government to handle those problems
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Banu, Roxana. "ASSUMING REGULATORY AUTHORITY FOR TRANSNATIONAL TORTS: AN INTERSTATE AFFAIR? A HISTORICAL PERSPECTIVE ON THE CANADIAN PRIVATE INTERNATIONAL LAW TORT RULES." Windsor Yearbook of Access to Justice 31, no. 1 (February 1, 2013): 197. http://dx.doi.org/10.22329/wyaj.v31i1.4321.

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In Tolofson v. Jensen, the Supreme Court of Canada determined that in most cases the law of the place where the tort occurred has exclusive authority to regulate all legal aspects related to it. In developing this choice of law rule, the Supreme Court relied on an analogy between Private International Law and Public International law. This allows Private International Law to claim a structural, neutral function in the distribution of legislative authority in the international realm and to ignore both private law and public law considerations. To best reveal the way in which the Supreme Court injected these limitations into Private International Law by reference to Public International Law, I show the striking similarity between the Supreme Court’s reasoning and several Private International Law writings at the end of the 19th century in Continental Europe. In the context of the extraterritorial tortious activity of multinational corporations, these limitations make Private International Law oblivious to arguments of Corporate Social Responsibility scholars showing that a multinational corporation may legitimately be regulated by the state of its headquarters, even for extraterritorial conduct. Overall, I argue that an overemphasis on legislative authority as a symbol of state sovereignty transforms Private International Law matters generally, and transnational torts in particular, in inter-state affairs, removed from the interests and pleas of the individuals and communities affected by them. Dans l’arrêt Tolofson c. Jensen, la Cour suprême du Canada a décidé que, dans la plupart des cas, la loi du lieu où le délit a été commis régit exclusivement tous les aspects juridiques qui s’y rapportent. Pour établir cette règle du choix de la loi applicable, la Cour suprême s’est fondée sur une analogie entre le droit international privé et le droit international public. Cela permet au droit international privé de réclamer une fonction structurelle et neutre au niveau de la distribution du pouvoir législatif dans le domaine international et d’ignorer tant les considérations de droit privé que les considérations de droit public. Pour mieux illustrer la façon dont la Cour suprême a inséré de telles restrictions dans le droit international privé par renvoi au droit international public, je démontre la similitude frappante entre le raisonnement de la Cour suprême et de nombreux écrits en droit international privé à la fin du 19e siècle en Europe continentale. Dans le contexte des activités délictueuses extraterritoriales des sociétés multinationales, de telles restrictions rendent le droit international privé insensible aux arguments des universitaires prônant la responsabilité sociale des entreprises selon lesquels une société multinationale peut légitimement être régie par l’État où est situé son siège social, même pour sa conduite extraterritoriale. Dans l’ensemble, je fais valoir qu’une trop grande importance accordée au pouvoir législatif comme symbole de la souveraineté étatique transforme les affaires relevant du droit international privé en général et les délits transnationaux en particulier en affaires interétatiques qui ne tiennent pas compte des intérêts et demandes des particuliers et collectivités qu’elles touchent.
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Dissertations / Theses on the topic "Regulatory Affair"

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Villa, Federico. "The determinants of market access for medicines: theoretical issues and empirical evidence." Doctoral thesis, Università del Piemonte Orientale, 2021. https://hdl.handle.net/11579/148544.

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To frame the determinants of drug prices within a complex regulatory system and how these determinants influence the P&R decisions of medicine, an analysis of the Italian reference context as a whole was done, starting from the trends in the use and consumption of drugs, to the analysis of the regulatory process and market access for specific categories of drugs, orphan drugs for rare diseases. Some of the system's shortcomings are the result of limited quality control as a whole over the years, which has led to the adoption of compartmentalized pharmaceutical policies without a medium-long term strategic vision integrating clinical, pharmacoeconomic, and organizational aspects. By critically analyzing the regulatory and access system that regulates the price and reimbursement of drugs, it was possible to: (i) verify the difficult coexistence, in some cases, of European early access strategies with a rapid and complete assessment of HTA at the national level (which frustrate efforts to promote faster drug access pathways); (ii) highlight how the perception of a drug's innovativeness produces different policies in the main regulatory agencies; (iii) to underline the different view of the value of a drug between the company and the payer; (iv) the use of non-standardized P&R criteria for the definition of P&R by AIFA for different products (even for the same therapeutic area); (v) as some classes of drugs, such as orphan drugs, have had a significant increase in terms of products developed thanks to strategies to encourage investment in a previously unprofitable sector, but how this increase has also led to a significant increase in expenditure due to a P&R model not related to the low epidemiology of these diseases and/or the real impact in terms of clinical benefits of these products.
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Costa, Sara Filipa Abrantes. "Training in regulatory strategy and regulatory affairs of health products." Master's thesis, Universidade de Aveiro, 2012. http://hdl.handle.net/10773/10587.

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Mestrado em Biomedicina Farmacêutica
O presente relatório descreve as atividades desenvolvidas como estagiária no departamento de Estratégia e Assuntos Regulamentares da empresa Eurotrials, Consultores Científicos, empresa especializada na investigação clínica e consultoria científica na área da saúde. O objetivo principal desta experiência de 9 meses era um primeiro contacto com mundo do trabalho, consolidando e aprofundando os conteúdos abordados no Mestrado em Biomedicina Farmacêutica. Os Assuntos Regulamentares estão fortemente envolvidos em todo o processo de desenvolvimento do produto, desde a ideia inicial ao final do seu ciclo de vida. Tendo em conta a variedade de atividades com as quais tive oportunidade de lidar, ao longo deste relatório incluí a minha perspetiva em relação à natureza multidisciplinar que envolve a temática dos Assuntos Regulamentares.
This report describes the activities performed as a trainee in the Regulatory Strategy and Regulatory Affairs department of Eurotrials, Scientific Consultants, a company specialized in clinical research and scientific consultancy in the area of health. The main objective of this 9-month experience was the first contact with the employment world, with consolidation and deeper understanding of the contents approached in the Master in Pharmaceutical Biomedicine. Regulatory Affairs are strongly involved in the entire process of the product development, since the initial idea to the end of its life-cycle. Taking into account the variety of activities I had the opportunity to deal with, in the course of this report I included my own perspective regarding the multidisciplinary nature of Regulatory Affairs.
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Dhanraj, Keshnee. "Perceptions of the pharmaceutical industry and regulators in South Africa towards registration harmonisation in the Southern African Development Community (SADC)." University of the Western Cape, 2021. http://hdl.handle.net/11394/7956.

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Magister Pharmaceuticae - MPharm
Medicines have to be regulated in an effort to monitor their quality, safety, and efficacy. The process of medicines registration is lengthy, costly, and document-heavy. Many countries have limited expertise and resources at national medicines regulatory authorities (NMRAs) and some countries have adopted unified approaches to medicines registration legislation. Harmonised guidelines and initiatives have been adopted in South Africa and the Southern African Development Community (SADC). However, there are no studies that have identified the effects of these initiatives and guidelines on major stakeholders such as the pharmaceutical industry and regulators.
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Pinho, Bárbara Marina da Silva. "Regulatory affairs role in a multinational pharmaceutical company." Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/12967.

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Mestrado em Biomedicina Farmacêutica
The present monograph intends to present a Regulatory Affairs department at a Multinational Pharmaceutical Company, as well as the role of the professionals working in that department. The experience which led to this monograph occurred after the conclusion of the curricular part of the Masters in Pharmaceutical Medicine, and was an opportunity to apply all the knowledge previously acquired and to develop new technical and personal skills. After the contextualisation of this document, the first chapter of this monograph introduce the Regulatory Affairs Professionals describing their principal responsibilities inside of the team. Following this, the principal activities developed by these professionals are described as well as how they interact with the different stakeholders. After framing the professional and the tasks developed, the structure of the modern Regulatory Affairs department is introduced and its impact on a Pharmaceutical Company is analysed. The following chapters promote a more personal view, showing the main activities developed during this professional experience and how the knowledge acquired prior and during it influenced the achieved results.
A presente monografia propõe apresentar um departamento de Assuntos Regulamentares de uma Empresa Multinacional Farmacêutica bem como o papel do Profissional que nele trabalha. A experiência que deu origem a esta monografia foi realizada após a conclusão da parte curricular do Mestrado em Biomedicina Farmacêutica, e foi uma oportunidade de aplicar todos os conhecimentos previamente adquiridos e de desenvolver novas competências técnicas e pessoais. Após a contextualização deste documento, o primeiro capítulo desta monografia introduz o Profissional de Assuntos Regulamentares, descrevendo as suas principais atividades dentro da equipa. De seguida, apresentam-se as atividades desenvolvidas por estes profissionais descrevendo-se como interagem com as diferentes partes envolvidas. Após o enquadramento do profissional e das atividades desempenhadas, introduz-se a estrutura de um departamento de Assuntos Regulamentares moderno e analisa-se o seu impacto numa empresa farmacêutica. Os seguintes capítulos promovem uma visão mais pessoal, mostrando as principais atividades desenvolvidas durante esta experiência e como os conhecimentos adquiridos antes e durante a mesma influenciaram os resultados adquiridos.
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Pinela, Raquel Alexandra Pires. "9 months experience as a trainee regulatory affairs officer." Master's thesis, Universidade de Aveiro, 2012. http://hdl.handle.net/10773/10900.

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Mestrado em Biomedicina Farmacêutica
O presente relatório tem como objetivo descrever as atividades desenvolvidas no âmbito do estágio curricular na área dos assuntos regulamentares, que decorreu entre 1 de Agosto de 2011 e 4 de Maio de 2012, no Departamento de Manutenção do Mercado da Phagecon – Serviços e Consultoria Farmacêutica, Lda.. Este estágio é parte integrante do programa de formação do mestrado em Biomedicina Farmacêutica e teve como principais objetivos a aquisição de experiência na realização das atividades comumente associadas aos assuntos regulamentares, bem como a consolidação de conhecimentos e o desenvolvimento de novas competências técnicas. O primeiro capítulo introduz o estágio curricular em assuntos regulamentares, seguindo-se uma descrição generalista do contexto regulamentar aplicável às atividades realizadas. Os capítulos e secções posteriores destinam-se a descrever a empresa que proporcionou o estágio, os objetivos para este definidos e as atividades e tarefas desempenhadas. Por último, será feita uma discussão crítica do estágio, incluído a análise das principais dificuldades sentidas e as competências adquiridas.
This report aims to describe the activities performed during the curricular internship in regulatory affairs, which took place from August 1, 2011 to May 4, 2012 at Marketing Maintenance Department of Phagecon – Serviços e Consultoria Farmacêutica, Lda.. The internship is an essential part of the training programme in Pharmaceutical Biomedicine and it main goals were: to gain experience in conducting common regulatory activities; to consolidate background knowledge and to develop new technical skills. The first chapter introduces the internship and is followed by a general description of the regulatory environment applicable to the activities performed. The later chapters and respective sections intend to: describe the hosting company, define internship goals and give a detailed description of the activities and tasks performed during this 9 months experience. Finally, it will be presented a critical discussion of internship outcomes, including the analysis of the main difficulties and key competences acquired.
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Mukoma, Collins. "Exploration of the Training/Educational Background and The Roles of Regulatory Affairs Associates/Officers in selected South African Based Pharmaceutical Companies in Gauteng Province." University of the Western Cape, 2004. http://hdl.handle.net/11394/8235.

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>Magister Scientiae - MSc
Regulatory Affairs (RA), within the pharmaceutical business, could be a profession that covers completely different registration parameters of a pharmaceutical product. This is often a replacement profession that was developed to shield public health by providing the smart quality pharmaceutical product as well as safety and efficacy. The study aimed to explore the coaching and role of RA associates/officers in pharmaceutical corporations in Gauteng, South Africa. The study was a cross-sectional survey, which utilized google forms with both open and closed-ended questions. Using descriptive statistics, it was found that, majority of the participants (78.3%) (RA assistants, officers, and scientists) indicated that most of the responsibilities they carry out were through informal training (i.e. learning on the job). However, even though various pharmaceutical companies have different titles for this personnel, it was observed that most of them perform almost the same functions (i.e. Prepare submissions of license variations and renewals to strict deadlines, with 91.3% of the participants learning the skills on the job). Furthermore, it was recorded that most RA personnel have experience of between 1-5 years (56.6 %) and that most RA personnel acquired their job through an internship (43.5%) and external vacancy (43.5%). Moreover, it was also observed that most RA personnel (43.5%) have more than one qualification (Honours Degree and MSc Degree). Although specialized training is required for RA personnel, only 30.4% of the participants were trained to provide strategic advice to senior management throughout the development of a new product. About 13.0% of the participants were trained to plan and develop product trials and interpret trial data.
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Kachirskaia, Ioulia. "Identifying a potential substrate of Plasmodium Falciparum cell cycle regulatory Kinase PFPK5." Honors in the Major Thesis, University of Central Florida, 2003. http://digital.library.ucf.edu/cdm/ref/collection/ETH/id/321.

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This item is only available in print in the UCF Libraries. If this is your Honors Thesis, you can help us make it available online for use by researchers around the world by following the instructions on the distribution consent form at http://library.ucf.edu/Systems/DigitalInitiatives/DigitalCollections/InternetDistributionConsentAgreementForm.pdf You may also contact the project coordinator, Kerri Bottorff, at kerri.bottorff@ucf.edu for more information.
Bachelors
Health and Public Affairs
Molecular Biology and Microbiology
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Bodnar, Olivia Verfasser], and Justus [Gutachter] [Haucap. "Five Empirical Essays on Antitrust and Regulatory Affairs / Olivia Bodnar ; Gutachter: Justus Haucap." Düsseldorf : Universitäts- und Landesbibliothek der Heinrich-Heine-Universität Düsseldorf, 2021. http://d-nb.info/1224679326/34.

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Williams, George. "Establishing an effective economic regulatory policy for the European airline industry." Thesis, Cranfield University, 1990. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.278751.

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Gooch, Rebecca L. "Television production, regulation and enforcement reasons for broadcasters' non-compliance and a weakened state of regulatory affairs." Thesis, London School of Economics and Political Science (University of London), 2012. http://etheses.lse.ac.uk/353/.

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This thesis examines a group of television-makers that aimed to circumvent the regulations affecting standards of content and to reshape the boundaries of permissible violent content. It also examines the regulators who, in a period of significant regulatory restructuring, were required to police those boundaries and protect viewers from ‘harmful’ or ‘offensive’ content, and programme-contributors from ‘unfair’ treatment. In doing so, the aim is to offer a broader, empirically rich understanding of the individual, organisational and external factors that can lead to non-compliance and the relaxation of regulatory affairs over time; and to understand how rules or regulations can get pushed and reshaped. My findings revealed that both regulators and television-makers were confronted by conflicting economic and public interest objectives/responsibilities, and that, due to a variety of individual, organisational and external-level factors, they tended to prioritise their economic obligations, and this led to a loosening of the standards of consumer protection. The factors that influenced television-makers’ and regulators’ decision-making, and thereby this sequence of events, included, but were not limited to, the government’s shift toward deregulation, technological advancements, changing politics, a competitive organisational culture and a lack of sufficient accountability for television-makers.
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Books on the topic "Regulatory Affair"

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Dumitriu, Helene I. Good drug regulatory practices: A regulatory affairs quality manual. Buffalo Grove, Ill: Interpharm Press, 1998.

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Society, Regulatory Affairs Professionals. Fundamentals of US regulatory affairs. 7th ed. Rockville, MD: RAPS, Regulatory Affairs Professionals Society, 2011.

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Fundamentals of international regulatory affairs. Rockville, Md: Regulatory Affairs Professionals Society, 2010.

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Society, Regulatory Affairs Professionals, ed. Fundamentals of US regulatory affairs. 8th ed. Rockville, MD: Regulatory Affairs Professionals Society, 2013.

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Canada. Office of Privatization and Regulatory Affairs. Information: Office of Privatization and Regulatory Affairs. Canada. S.l: s.n, 1987.

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Huml, Raymond A. Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional. New York, NY: Springer New York, 2012. http://dx.doi.org/10.1007/978-1-4614-3682-9.

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Tobin, Jack. Medical product regulatory affairs: Pharmaceuticals, diagnostics, medical devices. Weinheim: Wiley-Blackwell, 2008.

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Weller, Ryan. Internship with Burlington Environmental Inc. Regulatory Affairs Department, Spring 1992. Bellingham, Wash: Huxley College of Environmental Studies, Western Washington University, 1993.

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Regulatory management: A guide to conducting environmental affairs and minimizing liability. Chelsea, Mich: Lewis Publishers, 1991.

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J, Pisano Douglas, and Mantus David, eds. FDA regulatory affairs: A guide for prescription drugs, medical devices, and biologics. 2nd ed. New York: Informa Healthcare USA, 2008.

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Book chapters on the topic "Regulatory Affair"

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Guido, Ronald A., and Alan V. McEmber. "Regulatory Affairs." In Series in Biomedical Engineering, 187–97. New York, NY: Springer New York, 2008. http://dx.doi.org/10.1007/978-0-387-76495-5_18.

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Centanni, John M., and Michael J. Roy. "Regulatory Affairs." In Biotechnology Operations, 65–111. Second edition. | Boca Raton : CRC Press/Taylor & Francis, 2017. | Michael J. Roy’s name appears first in the previous edition.: CRC Press, 2016. http://dx.doi.org/10.1201/9781315367750-3.

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Mellan, R., and M. Kirst. "Regulatory affairs." In Forest genomics and biotechnology, 237–49. Wallingford: CABI, 2020. http://dx.doi.org/10.1079/9781780643502.0237.

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Rusia, Palchi. "Regulatory Strategy: An Overview." In Medical Affairs, 683–91. 3rd ed. New York: Jenny Stanford Publishing, 2021. http://dx.doi.org/10.1201/9781003207696-44.

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Goodwiler, Graham. "Regulatory Affairs and Intelligence." In The Palgrave Encyclopedia of Interest Groups, Lobbying and Public Affairs, 1–6. Cham: Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-13895-0_29-1.

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Beer, Christiane. "Nanotoxicology and Regulatory Affairs." In Advances in Delivery Science and Technology, 279–310. New York, NY: Springer New York, 2016. http://dx.doi.org/10.1007/978-1-4939-3634-2_12.

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Goodwiler, Graham. "Regulatory Affairs and Intelligence." In The Palgrave Encyclopedia of Interest Groups, Lobbying and Public Affairs, 1114–19. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-44556-0_29.

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Juuso, Ilkka. "Regulatory Affairs (SOP-11)." In Developing an ISO 13485–Certified Quality Management System, 227–36. New York: Productivity Press, 2022. http://dx.doi.org/10.4324/9781003202868-17.

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Kim, Young, Soo Kyeong Shin, and Jamie Noh. "Korea: Medical Device Regulatory System." In Medical Affairs, 535–71. 3rd ed. New York: Jenny Stanford Publishing, 2021. http://dx.doi.org/10.1201/9781003207696-35.

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Wong, Jack. "China: Medical Device Regulatory System." In Medical Affairs, 403–32. 3rd ed. New York: Jenny Stanford Publishing, 2021. http://dx.doi.org/10.1201/9781003207696-30.

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Conference papers on the topic "Regulatory Affair"

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Robinson, Jerry, Stephen Barnes, Mike Webb, and Gerry McCartor. "The Use of Pilot Modeling in Aviation Regulatory Affairs." In AIAA Modeling and Simulation Technologies Conference. Reston, Virigina: American Institute of Aeronautics and Astronautics, 2009. http://dx.doi.org/10.2514/6.2009-5825.

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Hradetzky, D., P. Etter, and E. Lucano. "Experience with a Continuous Education Program for Clinical, Regulatory and Quality Affairs in Northwestern Switzerland." In 2022 44th Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC). IEEE, 2022. http://dx.doi.org/10.1109/embc48229.2022.9871082.

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Héroult, M., F. Lioté, R. Champy, D. Barritault, and J. Courty. "THU0052 Heparin affin regulatory peptide (harp) in acute and chronic articular diseases." In Annual European Congress of Rheumatology, Annals of the rheumatic diseases ARD July 2001. BMJ Publishing Group Ltd and European League Against Rheumatism, 2001. http://dx.doi.org/10.1136/annrheumdis-2001.849.

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Sidhu, SK. "Scientific and Regulatory Affairs: Case Study: Crazy D's Soda: Opportunities to Make Evidence-based Health Statements on Foods." In Abstracts of the NHPRS – The 15th Annual Meeting of the Natural Health Products Research Society of Canada (NHPRS). Georg Thieme Verlag KG, 2018. http://dx.doi.org/10.1055/s-0038-1644972.

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Gouvêa, Denise de Campos, and Letícia Pacheco dos Passos Claro. "Challenges for The Implementation of The Regulatory Framework of Urban Land Regularization in Brazil’s Federal District." In 4th International Conference of Contemporary Affairs in Architecture and Urbanism – Full book proceedings of ICCAUA2020, 20-21 May 2021. Alanya Hamdullah Emin Paşa University, 2021. http://dx.doi.org/10.38027/iccaua2021260n4.

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This article seeks to reflect on the current legal framework for urban land regularization, Federal Law No. 13,465/2017, and to explore the challenges of Brazil’s Federal District, the country's capital, to implement this recent Law. Questions about the proposed new paradigms that favor a privatist logic of urban property characterized especially from an asset in the financial market and with great profitability. This research also exposes the methodology for identifying informal settlements with urban characteristics in the Federal District, especially the areas with the most vulnerable population, to subsidize the inclusion of new areas of urban land regularization in the local regulatory framework.
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Dobrić Jambrović, Dana. "CROATIAN CITIES DURING THE COVID-19 CRISIS: CHALLENGES, RESPONSES AND ADJUSTMENTS." In EU 2021 – The future of the EU in and after the pandemic. Faculty of Law, Josip Juraj Strossmayer University of Osijek, 2021. http://dx.doi.org/10.25234/eclic/18359.

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The main research question of the paper is related to the identification and analysis of the challenges that Croatian local units face during the crisis caused by the COVID-19 pandemic. First, the regulatory framework of the civil protection system was presented to determine a direction of research of organizational and functional adjustments of local units for effective crisis management. Empirical research was conducted using the data content analysis (legal regulations, strategic documents, soft law documents, and web sourced data). Research findings have shown that local units face challenges in the areas of political governance, administrative and professional affairs, local budget, and the implementation of local democracy mechanisms. Therefore, in each of the identified areas, the author has analyzed elements that are subject to adaptation to national recommendations to reduce the spread of coronavirus. In doing so, attention is focused on large cities and county centers and their adjustments during crisis management were analyzed.
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Upshall, Ian. "The British Radwaste Information Management System (BRIMS)." In ASME 2003 9th International Conference on Radioactive Waste Management and Environmental Remediation. ASMEDC, 2003. http://dx.doi.org/10.1115/icem2003-4808.

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The creation and subsequent access to accurate information is widely accepted as a vital component of a national radioactive waste management strategy. Information on the origin and quantity of the waste together with its physical, chemical and radiological characteristics provides a catalyst for sound and transparent decision making. This information will originate from a number of potentially disparate sources, including material manufacturers, facility operators, waste producers, Government and Non-Government organisations and regulators. The challenge to those with a role in information management in further increased by the fact that much of the information created is required to support activities, not only in the immediate future, but also in the longer-term — typically many decades or even centuries. The International Atomic Energy Agency (IAEA) has published a number of guidance documents under the Safety Series, one of which makes direct reference to information management. The document [1] is intended to assist Member States in the development of a national system for radioactive waste management and identifies the key responsibilities and essential features of such a system. The following statement appears in Section 5: “The regulatory body, the waste generators and the operators of radioactive waste management facilities should maintain documentation and records consistent with the legal requirements and their own needs.” An essential requirement of these ‘documents and records’ is that they should be “...kept in a condition that will enable them to be consulted and understood later by people different from, and possibly without reference to, those who generated the records ...” The scope of the documentation and records to be kept will be wide ranging but will include “...an inventory of radioactive waste, including origin, location, physical and chemical characteristics, and, as appropriate a record of radioactive waste removed or discharged from a facility”, and “site plans, engineering drawings, specifications and process descriptions ... radioactive waste package identification ...”. It is has long been recognised in the United Kingdom that the management of radioactive waste will require the assembly and secure retention of a diversity of records and data. This information will be needed to inform the strategic decision making process, thus contributing to the future safe, environmentally sound and publicly acceptable management of radioactive waste. In the meantime it will also service the nation’s international commitments. When the planning application for a Rock Characterisation Facility (RCF) was refused and the subsequent Nirex appeal rejected in 1997, it was recognised that transfer of waste to a national repository was ulikely to take place for many decades. The long-term preservation of information by the waste management organisations thus became an issue. Since this time, the UK nuclear industry, including the waste producers, regulators and other Government Departments have worked together to develop a common information management system that is now being implemented. It is based on an Oracle database and is supported by ‘electronic tools’ designed to facilitate entry and retrieval of data in a common format. Long-term access to these data underpins many aspects of the system design. Designing such a system and seeing through its development has been a challenge for all those involved. However, as the project nears the completion of the development phase, it is clear there are several benefits in this approach. These include a sharing of best practice, shared development costs, an improved understanding of the needs of all parties, and the use of a common platform and tools. The ‘partnership approach’ between waste management organisations, Government departments and regulators will also reduce the likelihood of future surprises or conflicts of interest. Industry-wide co-operation also provides a greater degree of confidence that the system will continue to enjoy technical and financial support for the foreseeable future. The British Radwaste Information Management System (BRIMS) is supported by the principal waste producers, the Department for Environment, Food and Rural Affairs (DEFRA), the Nuclear Installations Inspectorate (NII) and United Kingdom Nirex Limited (Nirex). All organisations that have participated in its development over the past seven years have free access to it and may use it as part of their waste management strategy.
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Mattingly, George E. "Establishing the International Acceptability of Fluid Quantity and Flow Rate Measurements (Invited Paper)." In ASME 2002 Joint U.S.-European Fluids Engineering Division Conference. ASMEDC, 2002. http://dx.doi.org/10.1115/fedsm2002-31078.

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Rapid advances in technology-communications, the internet, tele-marketing, travel, etc. are accelerating the globalization of the world’s market places. To facilitate this globalization by eliminating measurement-based barriers to trade, the International Committee on Weights and Measures (CIPM) has, in accord with the authority granted it by the International Treaty of the Meter, produced a Mutual Recognition Arrangement (MRA). This MRA, signed into existence in Oct 1999, has the objectives: 1. to establish the degree of equivalence of national measurement standards maintained by the National Metrology Institutes (NMIs) that have signed the MRA, 2. to provide for the mutual recognition of calibration and measurement certificates issued by the NMIs, and thereby 3. to provide governments and other parties with a secure technical foundation for wider agreements regarding measurements that relate to international trade, commerce, and regulatory affairs. Information on the CIPM, and the MRA can be found on the website: http://www.bipm.org/. Degrees of equivalence between and among national measurement standards are based on the results of Key Comparisons (KCs) conducted within the Consultative Committees of the CIPM. Flow measurement efforts are being addressed by the newly formed Working Group for Fluid Flow (WGFF) of the CIPM Consultative Committee on Mass and Related Quantities (CCM). The WGFF efforts are organized into six, specific measurement areas: water, hydrocarbon liquid, air speed, liquid volume, high pressure gas, and low pressure gas flow. In each of these areas, and according to MRA rules, the efforts are to design and conduct KCs that quantify the equivalence of the flow standards maintained in the participating NMIs. To determine appropriate operating ranges for KC’s, the WGFF is reviewing the Calibration and Measurement Capabilities (CMCs) of the participating NMIs. This presentation will briefly describe the MRA and the current WGFF plans and programs to conduct the KC tests. Specific techniques planned for the KCs will be to design flow meter transfer standards comprised of tandem arrangements of flow meters that are tested in the selected fluid and flow conditions to quantify the performance of NMI flow standards under actual conditions of use. Statistically sufficient and metrologically sound test protocols are being devised to efficiently and effectively produce the required data bases. Youden graphical analysis of variance and other statistical techniques are planned to analyze the resulting data. The results of these WGFF efforts are expected to make it feasible for flow measurements made anywhere in the world to be understood and acceptable anywhere else.
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Reports on the topic "Regulatory Affair"

1

Morin, Carl R., Atienza Jr., and Corazon. Regulatory Affairs. Fort Belvoir, VA: Defense Technical Information Center, October 1995. http://dx.doi.org/10.21236/ada300594.

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Horowitz, Arthur M. Drug Regulatory Affairs. Fort Belvoir, VA: Defense Technical Information Center, July 1987. http://dx.doi.org/10.21236/ada200081.

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Horowitz, Arthur M. Drug Regulatory Affairs. Fort Belvoir, VA: Defense Technical Information Center, July 1988. http://dx.doi.org/10.21236/ada206334.

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Larson, J., S. Peterson, K. Wilson, B. Bowen, D. MacQueen, and A. Wegrecki. Environmental Protection Department Operations and Regulatory Affairs Division LLNL NESHAPs 2005 Annual Report. Office of Scientific and Technical Information (OSTI), June 2006. http://dx.doi.org/10.2172/898472.

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Larson, J., S. Peterson, and K. Wilson. Environmental Protection Department, Operations and Regulatory Affairs Division, LLNL NESHAPs 2006 Annual Report. Office of Scientific and Technical Information (OSTI), June 2007. http://dx.doi.org/10.2172/921761.

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Levy, R. Environmental Protection Department Operations and Regulatory Affairs Division Contingency Plan for Site 300 Waste Accumulation Area(s). Office of Scientific and Technical Information (OSTI), July 2005. http://dx.doi.org/10.2172/877745.

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