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  • About
  • The Global ETD Search service is a free service for researchers to find electronic theses and dissertations. This service is provided by the Networked Digital Library of Theses and Dissertations.
    Our metadata is collected from universities around the world. If you manage a university/consortium/country archive and want to be added, details can be found on the NDLTD website.
1

The Rise and Recession of Medical Peer Review in New South Wales, 1856-1994

Thomas, David Gervaise January 2002 (has links)
The exercise of autonomy and self-regulation is seen in the literature as one of the basic criteria of professionalism. Since in modern states Medicine has generally been the occupational grouping which has most completely attained that status, it is seen as the model or archetype of professionalism. This study focuses on just one aspect of medical autonomy, that relating to the right of medical professionals to be accountable only to their fellow professionals as far as the maintenance of practice standards are concerned. In this thesis, the theory underlying this system of "peer review" is examined and then its application during the course of the 20th century is traced in one particular jurisdiction, that of the State of New South Wales in Australia. The reason for the focus on NSW is that in this jurisdiction, medical autonomy existed and was exercised in a particularly pure and powerful form after it was instituted in 1900. However, it was also in NSW that for the first time anywhere in the world, an institutional challenge to medical disciplinary autonomy emerged with the establishment in 1984 of the "Complaints Unit" of the Department for Health. The thesis of this study is that as a result of this development, which within a comparatively short space of time led to the emergence of a system of "co-regulation" of medical discipline, medical disciplinary autonomy and peer review had within a decade, been so severely challenged as to be almost extinct in this State. In the light of theoretical frameworks provided by Weber, Habermas and the American scholar Robert Alford, the study examines the long drawn out struggle to institute medical autonomy in NSW in the 19th century, its entrenchment by subsequent legislation over the next eight decades and the "counter-attack" staged by the emergent forces of consumerism, supported by the forces of the ideology of "Public Interest Law" in the last two decades of the century. The study concludes with a discussion of the implications for definitions of professionalism which might result from the loss by Medicine in NSW, of its right to exclusive control of medical discipline and the consequent disappearance of medical peer review.
2

The Rise and Recession of Medical Peer Review in New South Wales, 1856-1994

Thomas, David Gervaise January 2002 (has links)
The exercise of autonomy and self-regulation is seen in the literature as one of the basic criteria of professionalism. Since in modern states Medicine has generally been the occupational grouping which has most completely attained that status, it is seen as the model or archetype of professionalism. This study focuses on just one aspect of medical autonomy, that relating to the right of medical professionals to be accountable only to their fellow professionals as far as the maintenance of practice standards are concerned. In this thesis, the theory underlying this system of "peer review" is examined and then its application during the course of the 20th century is traced in one particular jurisdiction, that of the State of New South Wales in Australia. The reason for the focus on NSW is that in this jurisdiction, medical autonomy existed and was exercised in a particularly pure and powerful form after it was instituted in 1900. However, it was also in NSW that for the first time anywhere in the world, an institutional challenge to medical disciplinary autonomy emerged with the establishment in 1984 of the "Complaints Unit" of the Department for Health. The thesis of this study is that as a result of this development, which within a comparatively short space of time led to the emergence of a system of "co-regulation" of medical discipline, medical disciplinary autonomy and peer review had within a decade, been so severely challenged as to be almost extinct in this State. In the light of theoretical frameworks provided by Weber, Habermas and the American scholar Robert Alford, the study examines the long drawn out struggle to institute medical autonomy in NSW in the 19th century, its entrenchment by subsequent legislation over the next eight decades and the "counter-attack" staged by the emergent forces of consumerism, supported by the forces of the ideology of "Public Interest Law" in the last two decades of the century. The study concludes with a discussion of the implications for definitions of professionalism which might result from the loss by Medicine in NSW, of its right to exclusive control of medical discipline and the consequent disappearance of medical peer review.
3

Avaliação dos atendimentos realizados pelo Serviço Móvel de Urgência (SAMU) de Bauru / Evaluation of the services performed by the Urgency Mobile Service (SAMU) of Bauru

Alves, Rafael Arruda 01 August 2018 (has links)
Submitted by Rafael Arruda Alves (alves.a.rafael@gmail.com) on 2018-09-02T19:03:08Z No. of bitstreams: 1 Tese Final de Rafael Arruda Alves.pdf: 2482600 bytes, checksum: 9403ffa0524bb4525d6449decfc63f9f (MD5) / Approved for entry into archive by Sulamita Selma C Colnago null (sulamita@btu.unesp.br) on 2018-09-03T16:22:03Z (GMT) No. of bitstreams: 1 alves_ap_me_bot.pdf: 2482600 bytes, checksum: 9403ffa0524bb4525d6449decfc63f9f (MD5) / Made available in DSpace on 2018-09-03T16:22:03Z (GMT). No. of bitstreams: 1 alves_ap_me_bot.pdf: 2482600 bytes, checksum: 9403ffa0524bb4525d6449decfc63f9f (MD5) Previous issue date: 2018-08-01 / A Urgência e Emergência se constitui em um importante componente da assistência à saúde, principalmente devido ao crescimento do número de acidentes e da violência urbana. O Serviço de Atendimento Móvel de Urgência (SAMU) foi criado pelo governo federal em 2003 com função tanto operacional, voltada para os atendimentos pré-hospitalares através das ambulâncias de suporte básico de vida (USB) e suporte avançado de vida (USA), quanto pela central de regulação das urgências, que atende aos chamados telefônicos do 192, com papel de organizar os fluxos de atenção integral às urgências. Essa organização permite proporcionar dados provenientes de seu funcionamento que devem servir como importante ferramenta para o planejamento de ações estratégicas para saúde regional. O SAMU de Bauru foi iniciado em 2004 com três ambulâncias, passando a um serviço regional em 2011, abrangendo dezessete munícipios, atualmente, dispõe de duas motos (URAM), sete ambulâncias de suporte básico e duas de suporte avançado, ligadas através da central reguladora com oito bases descentralizadas instaladas em munícipios da região, atendendo uma área de 5.312,399km² e 634.195 habitantes. Emerge deste contexto o problema da presente pesquisa, desenhado a partir do questionamento sobre os resultados nas condutas pré-hospitalares e do processo de trabalho da central de regulação das urgências do município de Bauru, visando mensurar a contribuição com a assistência da urgência ao longo dos anos, cooperando para as ações de planejamento futuras, através de dados norteadores que possibilitem a construção de diretrizes técnicas. Os atendimentos realizados pelo SAMU Bauru regional no período de 7 anos foram analisados quanto ao tipo de ocorrência, variabilidade sazonal e adequação da regulação, e nesse período houve uma média de 8985 chamadas telefônicas/mês, sendo 83% delas reguladas, resultando em 242.162 em atendimentos. Destes, 67% se referiam a causas clínicas, 23% a emergências traumáticas, 9% foram classificados como outros tipos de causa, e 3537 resultaram em óbitos, o que representa 1,5% de todas as ocorrências realizadas. Para esclarecimento do perfil dos usuários, foi organizada uma estratificação dos dados desta série histórica com foco no ano de 2016, que permite confirmar que o SAMU é um observatório valioso da saúde loco regional, pois não apenas se configura como um importante serviço de atendimento ao usuário em suas necessidades de saúde, como também se mostra uma peça gestora de importância para organização da rede de saúde, atuando como um termômetro destas atuações, uma vez que a maior parcela da população ao ligar para o 192 tem uma necessidade real, seja por dificuldade ou impedimento de acesso a uma unidade de saúde, por um problema real de seus agravos clínicos, ou por eventos agudos e súbitos. / Emergency and Urgent Care is an important component of health care, mainly due to the increase in the number of accidents and urban violence. The Emergency Mobile Care Service (SAMU) was created by the federal government in 2003 with both an operational function aiming prehospital care through ambulances of basic life support (USB) and advanced life support (USA), as well as by the emergency regulation center, which attends the calls to the 192 line, with the role of organizing the flows of integral attention to the to provide data from its functioning that should serve as important tools for the planning of strategic actions for regional health. The SAMU of Bauru started serving in 2004 with three ambulances, becoming a regional service in 2011, covering seventeen municipalities, and currently has two motorcycles (URAM), seven ambulances of basic support and two of advanced support, linked through the regulation central by eight decentralized bases installed in municipalities in the region, serving an area of 5,312,399km² and 634,195 inhabitants. It emerges from this context the problem of the present research, designed by the questioning about the results in the prehospital conducts and the work process of the regulation center of urgencies in the city of Bauru, aiming to measure the contribution offered by the assistance of the urgency over the years, cooperating for the actions of future planning, through guiding data that enabled the construction of technical guidelines. SAMU Bauru regional consultations in the 7-year period were analyzed by type of occurrence, seasonal variability and adequacy of regulation. There was an average of 8985 telephone calls per month, which 83% were regulated, resulting in 242,162 consultations, 67% referred to clinical reasons, 23% were due to traumatic emergencies, 9% were classified as other causes, and 3537 were fatal victims, representing 1.5% of all occurrences. In order to clarify the profile of the users, a stratification of the data of this historical series was carried out focusing on the year 2016, confirming that SAMU is a valuable regional loco health observatory, and not only an important service of attending the user to its needs It is clear that the largest part of the population, when to call 192, has a real need, either due to difficulty or impediment of access to health services, a health unit, and a real problem of their clinical problems, or by sudden and acute events.
4

Avaliação dos atendimentos realizados pelo Serviço Móvel de Urgência (SAMU) de Bauru

Alves, Rafael Arruda January 2018 (has links)
Orientador: Adriana Polachini do Valle / Resumo: A Urgência e Emergência se constitui em um importante componente da assistência à saúde, principalmente devido ao crescimento do número de acidentes e da violência urbana. O Serviço de Atendimento Móvel de Urgência (SAMU) foi criado pelo governo federal em 2003 com função tanto operacional, voltada para os atendimentos pré-hospitalares através das ambulâncias de suporte básico de vida (USB) e suporte avançado de vida (USA), quanto pela central de regulação das urgências, que atende aos chamados telefônicos do 192, com papel de organizar os fluxos de atenção integral às urgências. Essa organização permite proporcionar dados provenientes de seu funcionamento que devem servir como importante ferramenta para o planejamento de ações estratégicas para saúde regional. O SAMU de Bauru foi iniciado em 2004 com três ambulâncias, passando a um serviço regional em 2011, abrangendo dezessete munícipios, atualmente, dispõe de duas motos (URAM), sete ambulâncias de suporte básico e duas de suporte avançado, ligadas através da central reguladora com oito bases descentralizadas instaladas em munícipios da região, atendendo uma área de 5.312,399km² e 634.195 habitantes. Emerge deste contexto o problema da presente pesquisa, desenhado a partir do questionamento sobre os resultados nas condutas pré-hospitalares e do processo de trabalho da central de regulação das urgências do município de Bauru, visando mensurar a contribuição com a assistência da urgência ao longo dos anos, cooperando para as ... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: Emergency and Urgent Care is an important component of health care, mainly due to the increase in the number of accidents and urban violence. The Emergency Mobile Care Service (SAMU) was created by the federal government in 2003 with both an operational function aiming prehospital care through ambulances of basic life support (USB) and advanced life support (USA), as well as by the emergency regulation center, which attends the calls to the 192 line, with the role of organizing the flows of integral attention to the to provide data from its functioning that should serve as important tools for the planning of strategic actions for regional health. The SAMU of Bauru started serving in 2004 with three ambulances, becoming a regional service in 2011, covering seventeen municipalities, and currently has two motorcycles (URAM), seven ambulances of basic support and two of advanced support, linked through the regulation central by eight decentralized bases installed in municipalities in the region, serving an area of 5,312,399km² and 634,195 inhabitants. It emerges from this context the problem of the present research, designed by the questioning about the results in the prehospital conducts and the work process of the regulation center of urgencies in the city of Bauru, aiming to measure the contribution offered by the assistance of the urgency over the years, cooperating for the actions of future planning, through guiding data that enabled the construction of technical guidelines.... (Complete abstract click electronic access below) / Mestre
5

Ações de urgência e emergência no Estado do Ceará: uma proposta de organização a partir da implantação do atendimento pré-hospitalar / Action of urgency and Emergency in the State of Ceará-Brazil: a proposal of organization from the implantation of the prehospital emergency care

FEITOSA, Paulo Egidio dos Santos January 2008 (has links)
FEITOSA, Paulo Egidio dos Santos. Ações de urgência e emergência no Estado do Ceará: uma proposta de organização a partir da implantação do atendimento pré-hospitalar. 2008. 161f. – Dissertação (Mestrado) – Universidade Federal do Ceará, Programa de Pós-graduação em Avaliação de Políticas Públicas, Fortaleza (CE), 2008. / Submitted by Márcia Araújo (marcia_m_bezerra@yahoo.com.br) on 2013-09-27T11:34:17Z No. of bitstreams: 1 2008-DIS-PESFEITOSA.pdf: 1163661 bytes, checksum: 17c2834917ee96c5642798ffc9e35ec1 (MD5) / Approved for entry into archive by Márcia Araújo(marcia_m_bezerra@yahoo.com.br) on 2013-09-27T11:35:14Z (GMT) No. of bitstreams: 1 2008-DIS-PESFEITOSA.pdf: 1163661 bytes, checksum: 17c2834917ee96c5642798ffc9e35ec1 (MD5) / Made available in DSpace on 2013-09-27T11:35:14Z (GMT). No. of bitstreams: 1 2008-DIS-PESFEITOSA.pdf: 1163661 bytes, checksum: 17c2834917ee96c5642798ffc9e35ec1 (MD5) Previous issue date: 2008 / This study, descriptive, aimed to develop a proposal for organizing the State System of Urgency and Emergency in the state of Ceará-Brazil, based on the deployment of the prehospital emergency care. Proposes the design of regional services in the optics of prehospital care with emphasis on the completeness of care and integration of services, qualification and the humanization of attention. Based on data from DATASUS and IBGE, year 2003, in conformity with a Minister of Health Order nº 2048/2003-GM-MS, were defined 12 regional clusters of urgency/emergency, with the same number of centrals regulation (11 to be implanted), 133 ambulances are needed for basic support (USB in portuguese) and 28 ambulances for advanced support (USA in portuguese). The necessary staff will be: 396 physicians, 396 nurses, 737 assistant/technical nursing, 660 ambulance drivers, 11 pharmacists, 110 telephone operators, among others. It was analyzed the admissions quantitative made in 20 poles hospitals in relation to the intervals of distance from the place of domicile. The occupation of beds is, in its majority, made by people of the municipality where the hospital is located. Based on the features of the Act Order of a Minister of Health nº 1101/GM-MS and according to the pole-regional grouping suggested, an analysis was made to verify the amount of beds available. It was obeyed that the number of beds is insufficient, more worrying is the situation of the ICU beds. As for the types of procedures of emergency, in the comparison between the poles, by frequency, there is greater focus on admissions for carrying out deliveries, cesarean sections and curettage post-abortion. It is suggested that the implementation of services should be done gradually with priority to the most underprivileged regions. In the re agreement of occupation of the beds in poleregional hospitals there should be clear a fair percentage for the types of procedures to be used by residents of the municipalities in regional coverage area, with definition of a standardized portfolio of hospital services, targeting self-sufficiency of emergency care at micro and macrorregional health in the state of Ceara. / Este estudo, descritivo, teve como objetivo elaborar uma proposta para organização do Sistema Estadual de Urgência e Emergência no estado do Ceará-Brasil, baseado na implantação de serviços de atendimento pré-hospitalar de urgência e emergência. Propõe o desenho de regionalização dos serviços na ótica do atendimento pré-hospitalar com ênfase na integralidade da atenção e integração dos serviços, da qualificação e da humanização da atenção. Com base nos dados do Datasus, e IBGE, ano 2003 e de acordo com o estabelecido pela Portaria GM-MS 2048/2003, foram definidos 12 pólos regionais de urgência e emergência com o mesmo número de centrais de regulação (11 a serem implantadas). São necessárias 133 ambulâncias de suporte básico (USB) e 28 ambulâncias de suporte avançado (USA). O pessoal necessário será: 396 médicos, 396 enfermeiros, 737 auxiliares/técnico de enfermagem, 660 condutores socorristas, 11 farmacêuticos, 110 telefonistas, entre outros. Foi analisado o quantitativo de internações realizadas nos 20 hospitais pólos em relação a intervalos de distância do local da residência. A ocupação dos leitos é em sua maioria feita pelos residentes dos municípios onde o hospital está localizado. Com base nos parâmetros do Ato Portaria nº 1101/GM-MS e de acordo com o agrupamento pólo-regional sugerido foi analisado o quantitativo de leitos disponíveis, verificou-se que o número de leitos é insuficiente, sendo mais preocupante a situação dos leitos de UTI. Quanto aos tipos de procedimentos de urgência e emergência, na comparação entre os pólos, por freqüência, existe maior concentração nas internações para realização de partos, cesarianas e curetagem pós-aborto. Sugere-se que a implantação seja feita de forma gradual com prioridade para as regiões mais desassistidas. Na repactuação da ocupação dos leitos dos hospitais pólo-regionais deverá haver definição clara de um percentual eqüitativo para os tipos de procedimentos por internação a serem utilizados pelos moradores dos municípios da área de cobertura regional, com definição de um “portfólio” padronizado de serviços hospitalares, almejando auto-suficiência do atendimento de urgência e emergência a nível micro e macrorregional de saúde no estado do Ceará.
6

AÃÃes de urgÃncia e emergÃncia no Estado do CearÃ: uma proposta de organizaÃÃo a partir da implantaÃÃo do atendimento prÃ-hospitalar / Action of urgency and Emergency in the State of CearÃ-Brazil: a proposal of organization from the implantation of the prehospital emergency care

Paulo Egidio dos Santos Feitosa 30 November 2008 (has links)
CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior / Este estudo, descritivo, teve como objetivo elaborar uma proposta para organizaÃÃo do Sistema Estadual de UrgÃncia e EmergÃncia no estado do CearÃ-Brasil, baseado na implantaÃÃo de serviÃos de atendimento prÃ-hospitalar de urgÃncia e emergÃncia. PropÃe o desenho de regionalizaÃÃo dos serviÃos na Ãtica do atendimento prÃ-hospitalar com Ãnfase na integralidade da atenÃÃo e integraÃÃo dos serviÃos, da qualificaÃÃo e da humanizaÃÃo da atenÃÃo. Com base nos dados do Datasus, e IBGE, ano 2003 e de acordo com o estabelecido pela Portaria GM-MS 2048/2003, foram definidos 12 pÃlos regionais de urgÃncia e emergÃncia com o mesmo nÃmero de centrais de regulaÃÃo (11 a serem implantadas). SÃo necessÃrias 133 ambulÃncias de suporte bÃsico (USB) e 28 ambulÃncias de suporte avanÃado (USA). O pessoal necessÃrio serÃ: 396 mÃdicos, 396 enfermeiros, 737 auxiliares/tÃcnico de enfermagem, 660 condutores socorristas, 11 farmacÃuticos, 110 telefonistas, entre outros. Foi analisado o quantitativo de internaÃÃes realizadas nos 20 hospitais pÃlos em relaÃÃo a intervalos de distÃncia do local da residÃncia. A ocupaÃÃo dos leitos à em sua maioria feita pelos residentes dos municÃpios onde o hospital està localizado. Com base nos parÃmetros do Ato Portaria n 1101/GM-MS e de acordo com o agrupamento pÃlo-regional sugerido foi analisado o quantitativo de leitos disponÃveis, verificou-se que o nÃmero de leitos à insuficiente, sendo mais preocupante a situaÃÃo dos leitos de UTI. Quanto aos tipos de procedimentos de urgÃncia e emergÃncia, na comparaÃÃo entre os pÃlos, por freqÃÃncia, existe maior concentraÃÃo nas internaÃÃes para realizaÃÃo de partos, cesarianas e curetagem pÃs-aborto. Sugere-se que a implantaÃÃo seja feita de forma gradual com prioridade para as regiÃes mais desassistidas. Na repactuaÃÃo da ocupaÃÃo dos leitos dos hospitais pÃlo-regionais deverà haver definiÃÃo clara de um percentual eqÃitativo para os tipos de procedimentos por internaÃÃo a serem utilizados pelos moradores dos municÃpios da Ãrea de cobertura regional, com definiÃÃo de um âportfÃlioâ padronizado de serviÃos hospitalares, almejando auto-suficiÃncia do atendimento de urgÃncia e emergÃncia a nÃvel micro e macrorregional de saÃde no estado do CearÃ. / This study, descriptive, aimed to develop a proposal for organizing the State System of Urgency and Emergency in the state of CearÃ-Brazil, based on the deployment of the prehospital emergency care. Proposes the design of regional services in the optics of prehospital care with emphasis on the completeness of care and integration of services, qualification and the humanization of attention. Based on data from DATASUS and IBGE, year 2003, in conformity with a Minister of Health Order n 2048/2003-GM-MS, were defined 12 regional clusters of urgency/emergency, with the same number of centrals regulation (11 to be implanted), 133 ambulances are needed for basic support (USB in portuguese) and 28 ambulances for advanced support (USA in portuguese). The necessary staff will be: 396 physicians, 396 nurses, 737 assistant/technical nursing, 660 ambulance drivers, 11 pharmacists, 110 telephone operators, among others. It was analyzed the admissions quantitative made in 20 poles hospitals in relation to the intervals of distance from the place of domicile. The occupation of beds is, in its majority, made by people of the municipality where the hospital is located. Based on the features of the Act Order of a Minister of Health n 1101/GM-MS and according to the pole-regional grouping suggested, an analysis was made to verify the amount of beds available. It was obeyed that the number of beds is insufficient, more worrying is the situation of the ICU beds. As for the types of procedures of emergency, in the comparison between the poles, by frequency, there is greater focus on admissions for carrying out deliveries, cesarean sections and curettage post-abortion. It is suggested that the implementation of services should be done gradually with priority to the most underprivileged regions. In the re agreement of occupation of the beds in poleregional hospitals there should be clear a fair percentage for the types of procedures to be used by residents of the municipalities in regional coverage area, with definition of a standardized portfolio of hospital services, targeting self-sufficiency of emergency care at micro and macrorregional health in the state of Ceara.
7

生技製藥產業之技術商品化研究--由法規政策面分析 / A study on the commercialization of the intellectual property of biotechnology and pharmaceutical industry--Regulatory perspective

洪子秋, Hung,Tze Chiu Unknown Date (has links)
近年來在相關產業與政府的努力及人才培育之下,我國許多生技研究已有初步的規模且可說是居於亞洲領先地位。然而,這些技術在商品化應用的階段卻一直沒有重大突破與發展,難以將研發成果的實質效益挹注到產業中。研發成果商品化的過程中,必須兼備技術面、法律面、財務面、管理面的考量,面面俱到才能將初萌的技術逐步發展為成熟的商品,進而在市場上獲取實質利潤,再將獲得的資源挹注於研發活動,形成良性循環。 研發成果商品化的策略視產業特性而截然不同,在「生技醫療產業」中,因其具有「受衛生主管機關高度管制」、「商業化認證需時」、「行銷國際化」的特性,在法規面的複雜度較高,且為專案成功與否的關鍵因素之一,進行商品化評估時必須熟悉相關醫藥法規,才能著手為專案發展做正確的規畫 ,極度仰賴「跨領域」、「高度技術」與「熟稔特殊商業技巧」的人才。依各國藥物法規的不同,商品化的開發時程也受此影響,生技製藥產業之技術及研發成果必須將為達到法規規範的要求而必須投入的時間、資金、人力等各項資源納入總體可行性評估之考量依據。。因法規具有地域性,本研究無法齊備全球各國,將以美國及台灣為研究主體,台灣的法規深受世界公認醫藥法規先進的美國影響,熟知美國的法規可以預估台灣法規機構的思路;且美國藥品市場佔全世界最大規模,此外,美國也極有可能成為潛在合作廠商之所在地,因此本研究將比較美國與台灣之醫藥法規,並評估在技術研發的過程中,衛生主管機關之要求對於技術商品化過程中所產生的影響。 明確、具科學性、可預期性的法規環境能降低製藥產業於研發過程中的不確定性,提高廠商投入的意願。衛生醫療政策及藥政管理政策直接影響到醫藥法規的訂立,政府制定的法規將引導產業發展的方向,對於藥品市場有極重要的影響。一個好的政策應該能夠與國家的總體背景相匹配,法規要求應與國家發展程度及國家內需市場成比例。台灣生技製藥產業目前的困境之一,就是國內廠商在開發新藥時,為了符合台灣衛生主管機關訂定的高標準法規必須投入更多的成本,但台灣卻沒有足夠的內需市場得以支撐,造成擁有豐厚資源的國外廠商可以將符合世界(十大先進國)高標準的藥品進入台灣市場,但國內廠商卻無法立足。為解決此困境,台灣廠商一定要設法將業務範圍擴大到外需市場,以獲取足以支持藥物發展所需的資金成本。因此,了解國內、外之藥物相關法規,做出能符合各國法規要求的產品,為踏出國際外銷市場的第一步;此外,各國的智財法以及與商業相關的法律,還有其之間的互相關聯,都是技術商品化是否能夠成功至為重要的關鍵因素。本文擬就藥物法規面為討論之主軸,其間輔以智財、商業相關構面,對生技製藥產業之技術商品化之過程做一探討。在本研究所選的個案—核子醫學藥物,是眾多創新產品的一種,如果能把握技術、智財、法規、法律、國際商業運作,很有可能為台灣的藥業打開另一片天。 / In recent years, we have already developed some achievements in biotech researches in Taiwan and are in a leading position in Asia under the efforts of government and industries. However, these technologies still are slowly developed to the commercialized phase. Thus, the achievement of these researches does not benefit industry substantially. In the process of commercialization of biotech research, we have to consider all the aspects, including technology and regulation, intellectual property, finance and management. With a well-rounded development plan, technologies in the bud will gradually develop to a mature commodity, and earn fiscal profit in the market. The profit will consequently contribute to research activity. A virtuous circle will be formed. The strategies of commercialization differ considerably among industries. Regarding biopharmaceutical industry which has the properties of highly regulated by competent authorities, time consuming, heavy capital, and global marketing, the regulation assessment is not only complicate but also critical to project implementation. The required documents according by regional authorities will be a decisive factor to consider the development plan including the estimated timetable, needed resources. Due to the regulation system in US affected a lot legislation for laws in Taiwan , America and Taiwan will be the prior topics in this research. A well-developed legal framework and protection of intellectual property rights is the prerequisite for building an ideal environment where the biotechnology and pharmaceutical industries can flourish. In order to improve the environment for these industries, in recent years the government has approved the amendment and execution of related laws and regulations. Amendments have been made to related tax benefit and incentive measures of investment. Other amendments have been made which have allowed R&D results to be more easily transferred to academia and industry. Looking into the future, under the joint cooperation of industry, academia and research institutes, and with the government’s policy to fully promote the sector, it is believed that Taiwan will have well developed in the near future.

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