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Dissertations / Theses on the topic 'ICH Guidelines'

Author: Grafiati

Published: 2 June 2025

Last updated: 31 July 2025

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1

Vieira, Sandra Filipa Simões Fernandes. "Product quality and compliance in the pharmaceutical industry." Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/15680.

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Mestrado em Biomedicina Farmacêutica<br>This thesis aims to highlight the importance of a Product Quality & Compliance department in a Pharmaceutical Industry, on the good performance of company's activities and the achievement of their goals and mission. Despite the wide activities performed by this Department, the purpose of this work will be completed by describing only some of their reponsibilities. The tasks described are specifically the ones I have been performing throughout my professional experience at Bluepharma - Pharmaceutical Industry, SA, initiated in June 2012 in the Quality Ass

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2

Hawryluck, L. "Consensus guidelines on analgesia and sedation in dying ICU patients." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 1999. http://www.collectionscanada.ca/obj/s4/f2/dsk1/tape8/PQDD_0006/MQ46112.pdf.

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3

Nangue, Calvain Raoul. "Guidelines for the successful integration of ICT in schools in Cameroon." Thesis, Nelson Mandela Metropolitan University, 2011. http://hdl.handle.net/10948/1311.

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ICT integration in secondary schools in Sub-Saharan Africa is still at an early stage and already faces several setbacks that may undermine the various initiatives undertaken by governments and the private sector to promote the use of computers in schools. Based on literature and other research, this may be attributed to the fact that no guidelines for proper ICT adoption in secondary schools exist; and furthermore, most integration cases were done haphazardly with no systematic approach based on the existing frameworks or tailored towards the real context in the schools concerned. The present

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4

Mella, Luca. "Ict security: Testing methodology for targeted attack defence tools." Master's thesis, Alma Mater Studiorum - Università di Bologna, 2014. http://amslaurea.unibo.it/6963/.

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La tesi di laurea presentata si inserisce nell’ampio contesto della Sicurezza Informatica, in particolare tratta il problema del testing dei sistemi di sicurezza concepiti per contrapporsi alle odierne minacce: gli attacchi mirati (Targeted Attacks) ed in generale le minacce avanzate persistenti (Advanced Persistent Threats). Il principale obiettivo del lavoro svolto è lo sviluppo e la discussione di una metodologia di test per sistemi di sicurezza focalizzati su questo genere di problemi. Le linee guida proposte hanno lo scopo di aiutare a colmare il divario tra quello che viene testato e qu

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5

Blom, Olof, and Daniel Salomonsson. "Exploring the diffusion of e-learning : general and enabling guidelines for implementation of computer-aided teaching in developing countries." Thesis, Högskolan i Borås, Institutionen Handels- och IT-högskolan, 2012. http://urn.kb.se/resolve?urn=urn:nbn:se:hb:diva-16645.

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The purpose of the study was to create guidelines regarding effective diffusion of elearningto and within developing countries. Another aim of the study was to identifychallenges and problems related to the diffusion of e-learning, as well as identifying whatcharacterizes a successful ICT diffusion project. To achieve the purpose of the study acase study was performed in Thailand, where two different schools, i.e. two cases thathad been targeted by ICT diffusion projects were studied. In combination to studying theschools, the donor side of the project were also included in the study. The stud

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6

Heasman, Michael Kenneth. "Influence of changing patterns of sucrose consumption on industrial users. Response by manufacturers of soft drinks, biscuits, cereals, cakes confectionery, ice-cream, jams, canned products and other sugar-containing foods to the U. K. dietary guidelines that relate to sucrose consumption." Thesis, University of Bradford, 1988. http://hdl.handle.net/10454/4223.

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Sugar is intrinsically linked with the modern food system. Large sections of the U. K. food industry are dependent on its use and functional qualities. Supplies of sucrose entering the food chain have declined 25% between the 1950's and 1980's and currently stand around 37 kg/person/year. Furthermore, U. K. dietary guidelines over the past 14 years have consistently suggested caution over how much sugar is eaten, especially in manufactured foods. Dietary guidelines such as the NACNE report (1983) recommend average sugar consumption should be no more than 20 kg/person/year. Currently, tw

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7

Heasman, Michael Kenneth. "Influence of changing patterns of sucrose consumption on industrial users : response by manufacturers of soft drinks, biscuits, cereals, cakes confectionery, ice-cream, jams, canned products and other sugar-containing foods to the U.K. dietary guidelines that relate to sucrose consumption." Thesis, University of Bradford, 1988. http://hdl.handle.net/10454/4223.

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Sugar is intrinsically linked with the modern food system. Large sections of the U. K. food industry are dependent on its use and functional qualities. Supplies of sucrose entering the food chain have declined 25% between the 1950's and 1980's and currently stand around 37 kg/person/year. Furthermore, U. K. dietary guidelines over the past 14 years have consistently suggested caution over how much sugar is eaten, especially in manufactured foods. Dietary guidelines such as the NACNE report (1983) recommend average sugar consumption should be no more than 20 kg/person/year. Currently, two-third

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8

Hultqvist, Madeleine, and Michelle Lundkvist. "Följsamheten till nationella riktlinjer för centralvenösa infarter på intensivvårdsavdelning : En intervjustudie." Thesis, Linnéuniversitetet, Institutionen för hälso- och vårdvetenskap (HV), 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-95435.

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Bakgrund: Intensivvårdssjuksköterskan har en central roll beträffande hantering av centralvenösa infarter och det infektionsförebyggande arbetet som medföljer dem. Nationella riktlinjer för centralvenösa infarter är byggda utifrån evidens och patientsäkerhet. Trots detta så brister följsamheten vilket kan leda till förlängd vårdtid, vårdlidande och ökade samhällskostnader. Vad dessa brister beror på valdes att undersökas, utifrån ett intensivvårdssjuksköterskeperspektiv. Syfte: Syftet med studien var att belysa intensivvårdssjuksköterskans upplevelser av följsamhet till nationella riktlinjer f

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9

Huddleston, Brian J. "An Internship in Environmental Compliance and Water Management with Duke Energy Cincinnati, Ohio." Miami University / OhioLINK, 2011. http://rave.ohiolink.edu/etdc/view?acc_num=miami1303052585.

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10

Hajný, Jiří. "Management informační bezpečnosti ve zdravotnickém zařízení." Master's thesis, Vysoké učení technické v Brně. Fakulta podnikatelská, 2014. http://www.nusl.cz/ntk/nusl-224498.

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The diploma thesis focuses on implementation and deployment of information security management system (ISMS) into healthcare organizations. Specifies what is required to include in this process and what not to forget. It includes a risk analysis of a branch of the selected company, and for it is written a safety guide. Safety guide provides advice and recommendations regarding security in terms of human resources, physical security, ICT security and other aspects that should be included in the ISMS deployment in healthcare organizations. The work also reflects the newly emerging law on cyber s

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11

Ferreira, Diogo Filipe Lopes. "ICH Q8/Q9/Q10 guidelines : changing paradigm in pharmaceutical development." Master's thesis, 2014. http://hdl.handle.net/10316/28095.

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12

Sfalsini, Raisa Brêda Tôso. "Análise comparada dos requisitos regulamentares e científicos não-clínicos para o registro de novas moléculas no âmbito do Brasil e da ICH." Master's thesis, 2013. http://hdl.handle.net/10451/11389.

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Tese de mestrado, Regulação e Avaliação de Medicamentos e Produtos de Saúde, Universidade de Lisboa, Faculdade de Farmácia, 2013<br>A experiência internacional mostra que a cadeia de inovação da indústria farmacêutica depende de um marco regulatório eficiente para o seu desenvolvimento. Durante os últimos anos a Agência Nacional de Vigilância Sanitária (ANVISA) vem aperfeiçoando sua legislação regulatória com o objetivo de agregar qualidade, eficiência, segurança e confiabilidade aos estudos não-clínicos desenvolvidos no Brasil, bem como harmonizar sua legislação com os requisitos existentes e

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13

LIU, CHIN-MING, and 劉晉銘. "Analysis Solution of Implementation Strategy of ICH Q3D Guideline-Determination of Elemental Impurities in Film-Coating Tablet and Capsule Samples by ICP-MS." Thesis, 2018. http://ndltd.ncl.edu.tw/handle/j23f2x.

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碩士<br>國立高雄師範大學<br>化學系<br>106<br>This research aims at the determination of the potential elemental impurities which are not intentionally added in the commercial drug products. The particular elemental impurities listed in ICH Q3D for the oral route of administration were subjected to assess the drug product’s quality on the elemental impurities, including Class 1 (Cd, Pb, As and Hg), Class 2A (Co, V and Ni) and Class 3 (Li, Sb, Ba, Mo, Cu, Sn and Cr) elements. Film-coating tablets and capsule drug products were both selected as samples. Based on the analytical method proposed by Taiwan Foo

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14

Leendertz, Verona. "Guidelines for the professional development of Mathematics teachers in the pedagogical use of ICT in open distance learning / Verona Leendertz." Thesis, 2013. http://hdl.handle.net/10394/11569.

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Professional development (PD) of teachers is part of the Department of Basic Education‘s (DBE) initiative to encourage school communities to use of information and communication technology (ICT) to improve the quality of Mathematics teaching and learning. The South African Council of Educators stipulates that PD programmes should align with system-wide needs, strengthen learning area content and outcomes, and promote system transformation. Imbedded in this system-wide criterion is The White Paper on e-Education to employ a fully ICT integrated system at all levels of education: management, tea

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15

Perkins, Catharina Elizabetha. "The management of an information technology infrastructure in schools in the Western Cape Province." Diss., 2012. http://hdl.handle.net/10500/9266.

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This research conceptualises IT infrastructure management at secondary schools in the WCED (Western Cape Education Department). This includes whether or not secondary schools in the WCED make use of a full time, on-site network administrator or whether a teacher acts as on-site network administrator. The literature review studied the effectiveness of IT infrastructure management which includes hardware, software, policies, computer network, security; staff management and BYOD (bring your own device). The management of IT infrastructure at secondary schools within the WCED differs widel

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16

Jerzak, Natalia Malgorzata. "Heuristic evaluation for serious games : using heuristics, HESG, for designing and evaluating serious games." Master's thesis, 2013. http://hdl.handle.net/10400.5/13154.

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Heuristic evaluation has become an extensively acknowledged method of usability evaluation in software development. We can find several heuristics evaluations in the area of video games but there are no methods that would be taking into account serious games; specially crafted games and simulators that besides being connected with fun and entertainment are focusing on educational characteristics such as learning, training or habit formation. The existing usability inspections methods are having also certain limitations in use, the biggest difficulty is the huge influence of game industry in re

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