Academic literature on the topic 'Regulatory Affair'

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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 t
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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<br>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 produ
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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<br>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
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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<br>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 P
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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<br>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 consolidaç
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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<br>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 qu
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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.<br>Bachelors<br>Health and Public Affairs<br>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 rela
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