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1.
Journal of Public Health and Preventive Medicine ; (6): 121-124, 2024.
Article in Chinese | WPRIM | ID: wpr-1005921

ABSTRACT

The EU is a joint political and economic community organization of many countries. The formulation and implementation of its health strategy need to take into account the differences in the development level of public health among its member countries. Since 2003, the EU has completed the implementation of the third-generation health strategy and launched the fourth-generation health strategy in June 2021. Compared with previous generations of health strategies, EU4Health not only includes targeted measures to cope with COVID-19, but also analyzes the current health challenges in the EU, pointing out the direction for the future development of health in the EU. By introducing the basic health situation of the EU, sorting out the development process, content, and strategic indicators of the EU health strategy, and analyzing the implementation characteristics of EU4Health in the EU, this article aims to provide inspiration for the implementation and further improvement of the “Healthy China” strategy.

2.
Rev. bras. ciênc. esporte ; 45: e20230079, 2023. graf
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1529732

ABSTRACT

RESUMO O presente ensaio discute a Dupla Carreira (DC) em contexto europeu e a natureza simbiótica das habilidades adquiridas ao longo da vida, contribuindo para uma transição saudável ao mercado de trabalho no final da carreira esportiva. Nessa esteira evolutiva do suporte à DC fica evidente a produção conjunta do conhecimento em nível regional, nacional e internacional entre os Estados-Membros da União Europeia, assim como a proposição de políticas de amparo tanto aos atletas estudantes quanto aos atores que participam do processo de DC. A apresentação das Diretrizes para a DC em conjunto com os programas More Than Gold e EMPATIA ressaltam a importância do suprimento a nível micro, meso e macroestrutural, fornecendo experiências que induzem à ampliação do conceito de atleta estudante para sportsperson.


ABSTRACT This essay discusses the dual career (DC) in a European context and its symbiotic nature present in the skills acquired throughout life that contribute to a healthy transition to the job market at the end of the sports career. In this evolutionary path of DC support, the joint production of knowledge at a regional, national and international level, between the member states of the European Union, is evident, as well as the proposal of policies to support student athletes, and actors who participate in the DC process. The presentation of the Guidelines for DC and the More Than Gold and EMPATIA programs highlight the importance of supply at the micro, meso and macro structural level, experiences that induce the expansion of the concept of student athlete to sportsperson.


RESUMEN Este ensayo analiza la carrera dual (DC) en un contexto europeo y su naturaleza simbiótica presente en las habilidades adquiridas a lo largo de la vida que contribuyen a una transición saludable al mercado laboral al final de la carrera deportiva. Por lo tanto, el apoyo al DC destaca la producción conjunta de conocimiento a nivel regional, nacional e internacional, entre los estados miembros de la Unión Europea, así como la propuesta de políticas para apoyar a los estudiantes deportistas y actores que participan en el proceso de DC. La presentación de los Lineamientos para DC y los programas Más Than Gold y EMPATHY resaltan la importancia de ofrecer a nivel micro, meso y macro estructural, experiencias que induzcan a ampliar el concepto de estudiante deportista a sportsperson.

3.
International Journal of Traditional Chinese Medicine ; (6): 12-16, 2022.
Article in Chinese | WPRIM | ID: wpr-930094

ABSTRACT

Australia and EU Member States have been the important components of global herbal medicine market. The legal use of Chinese Materia Medica in Australia and EU Member States is closely related to the internationalization of Chinese medicine, therefore it is of great significance to conduct a comparative study on their herbal medicine registration regulations. By summarizing the regulations issued by Therapeutic Goods Administration (TGA) and European Medicines Agency (EMA), and comparing related definitions and the regulations on quality management and medicinal product registration, we found that the method No.3 of L (A) 3 and the traditional-use registration are more conductive to bringing Chinese patent medicines to market in Australia and the EU Member States.

4.
International Journal of Traditional Chinese Medicine ; (6): 6-11, 2022.
Article in Chinese | WPRIM | ID: wpr-930093

ABSTRACT

Europe occupies an important position in the world herbal medicine market. The registration of Traditional Chinese Medicine (TCM) in EU is of great significance to the internationalization of TCM. The European Medicines Agency (EMA) has designed a relatively complete management system and regulatory guidelines for the registration and supervision of herbal medicinal products. The promulgation of the DIRECTIVE 2004/24/EC (2004 / 24 / EC) indicates that TCM could enter the EU market through simplified registration. Based on the registration conditions, registration authority and document guideines of Traditional Herbal Medicinal Products (THMPs) in EU, this paper analyzes the application requirements of simple registration of traditional herbal products in EU, and provides suggestions for the simplified registration of TCM in EU according to the registration requirements of medicinal history, quality requirements and application data format.

5.
Texto & contexto enferm ; 31: e20210319, 2022.
Article in English | LILACS-Express | LILACS, BDENF | ID: biblio-1390490

ABSTRACT

ABSTRACT Objective: to understand the contributions of the Bologna Process to academic-professional mobility of Nursing. Method: a descriptive exploratory qualitative research. Open interviews were conducted with six PhD nurses, nursing professors, with more than 20 years of experience and who experienced the changes that occurred in higher education in post-Bologna nursing. The interviews took place in the Health or Nursing Schools of the north, center and south regions of Portugal, between January and March 2019, until saturation occurred by repetition. Content analysis was performed. Results: three perspectives are presented: 1) Mobility and internationalization as presuppositions to the strengthening of the economic bloc; 2) Mobility and internationalization contribute to the consolidation of a European identity; and 3) Diploma Supplement: fundamental aspect of academic-professional mobility. Conclusion: education proved to be a valid instrument for the construction of a common professional identity, considered indispensable for the strengthening of the block, with regard to the production of knowledge. The guidelines for the harmonization of university systems and the Diploma Supplement promoted scientific and cultural exchange through academic-professional mobility and intensified the dialogue between nations, which reverberate in social practices.


RESUMEN Objetivo: comprender las contribuciones del Proceso de Bolonia a la movilidad académico-profesional de Enfermería. Método: investigación cualitativa exploratoria descriptiva. Se realizaron entrevistas abiertas a seis enfermeros doctores, docentes de enfermería, con más de 20 años de experiencia y que vivieron los cambios que ocurrieron en la educación superior en la enfermería post Bolonia. Las entrevistas se realizaron en las Escuelas de Salud o Enfermería de las regiones norte, centro y sur de Portugal, entre enero y marzo de 2019, hasta que se produjo la saturación por repetición. Se realizó análisis de contenido. Resultados: se presentan tres perspectivas: 1) Movilidad e internacionalización como presupuestos para el fortalecimiento del bloque económico; 2) La movilidad y la internacionalización contribuyen a la consolidación de una identidad europea; y 3) Suplemento al Título: aspecto fundamental de la movilidad académico-profesional. Conclusión: la educación demostró ser un instrumento válido para la construcción de una identidad profesional común, considerada indispensable para el fortalecimiento del bloque, en lo que respecta a la producción de conocimiento. Los lineamientos para la armonización de los sistemas universitarios y el Suplemento al Título promovieron el intercambio científico y cultural a través de la movilidad académico-profesional e intensificaron el diálogo entre las naciones, que repercute en las prácticas sociales.


RESUMO Objetivo: compreender as contribuições do Processo de Bolonha para a mobilidade acadêmico-profissional de Enfermagem. Método: pesquisa descritiva, exploratória e de natureza qualitativa. Realizou-se entrevistas abertas com seis enfermeiros doutores, docentes de Enfermagem, com mais de 20 anos de atuação e que vivenciaram as mudanças ocorridas na formação superior em Enfermagem pós-Bolonha. As entrevistas ocorreram nas Escolas de Saúde ou de Enfermagem das regiões norte, centro e sul de Portugal, entre janeiro e março de 2019, até a saturação por repetição. Realizou-se análise de conteúdo. Resultados: apresentam-se três perspectivas: 1) A mobilidade e a internacionalização como pressupostos ao fortalecimento do bloco econômico; 2) A mobilidade e a internacionalização colaboram para a consolidação de uma identidade europeia; e 3) Suplemento ao Diploma: aspecto fundamental à mobilidade acadêmico-profissional. Conclusão: a educação provou ser um instrumento válido para a construção de uma identidade profissional comum, considerada indispensável para o fortalecimento do bloco, no que tange a produção de conhecimentos. As diretrizes para a harmonização dos sistemas universitários e o Suplemento ao Diploma promoveram o intercâmbio científico-cultural por meio da mobilidade acadêmico-profissional e intensificaram o diálogo entre as nações, que reverberam em práticas sociais.

6.
Cad. Ibero Am. Direito Sanit. (Impr.) ; 10(2): 211-232, abr.-jun.2021.
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1253860

ABSTRACT

A proteção de dados pessoais e a segurança informática são matérias sensíveis no setor da saúde. Este texto passa em revista o papel do responsável pelo tratamento de dados (data controller) segundo o Regulamento Geral de Proteção de Dados (RGPD). Estão em causa os princípios relativos ao tratamento e os direitos dos titulares de dados pessoais, os deveres de aplicar medidas técnicas e organizativas adequadas, de registar os tratamentos, de avaliar o impacto dos tratamentos ou, consoante os casos, de designar um encarregado de proteção de dados. São ainda analisadas as obrigações em matéria de segurança informática à luz do quadro legal aplicável, com destaque para a Diretiva europeia da cibersegurança.


Personal data protection and computer security are sensitive issues in the health sector. This work reviews the role of data controllers according to the General Data Protection Regulation (GDPR). At stake are the principles of data processing and the rights of holders of personal data, the duty to apply organized technical and organizational measures, to register treatments, to assess the impact of treatments or, as the case may be, to designate a data protection officer. Computer security obligations are also analysed under the applicable legal framework, in particular the EU Directiveon Cybersecurity.


La protección de los datos personales y la seguridad informática son cuestiones delicadas en el sector sanitario. Este trabajo revisa el rol del controlador de datos de acuerdo con el Reglamento General de Protección de Datos (RGPD). Em causa estão os princípios relativos ao tratamento e os direitos dos titulares de dados pessoais, os deveres de aplicar medidas técnicas e organizativas adequadas, de registar os tratamentos, de avaliar o impacto dos tratamentos ou, consoante os casos, de designar um encarregado de proteção de dados. Las obligaciones y materias de seguridad informática también se analizan a la luz del marco legal aplicable, en particular la Directiva de Ciberseguridad de la Unión Europea.

7.
Chinese Journal of Medical Instrumentation ; (6): 674-679, 2021.
Article in Chinese | WPRIM | ID: wpr-922081

ABSTRACT

By analyzing and comparing the IVD product classification supervision system in the EU's new IVDR, old IVDD and related guidance documents, concepts of related regulatory reforms were analyzed and explored, to provide references for industrial personnel to understand and master the new EU IVD classification system, and for China's ongoing classification management reform.


Subject(s)
European Union , Industry , Reagent Kits, Diagnostic
8.
China Journal of Chinese Materia Medica ; (24): 5450-5455, 2021.
Article in Chinese | WPRIM | ID: wpr-921726

ABSTRACT

Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.


Subject(s)
Humans , Adverse Drug Reaction Reporting Systems , Books , Drug-Related Side Effects and Adverse Reactions/epidemiology , European Union , Medicine, Chinese Traditional , Pharmacovigilance
9.
Chinese Journal of Biotechnology ; (12): 3401-3404, 2021.
Article in Chinese | WPRIM | ID: wpr-921435

ABSTRACT

Humanity shares the common interest to protect the environment and to maintain a healthy global ecosystem. International collaboration is key in this context, to advance the necessary science and technology. The National Science Foundation of China (NSFC) and European Commission (EC) have agreed to collaborate in innovative knowledge and technology in the field of bioremediation of polluted environments and biodegradation of plastics. In this context, projects on bioremediation of soils, wastewater and sediment matrices and on microbial degradation of plastics were supported. This special issue aimed to introduce these projects and their progresses in the related fields. In total, 23 papers have been collected in this issue, covering both fundamental and applied researches.


Subject(s)
Biodegradation, Environmental , China , Ecosystem , Plastics
10.
China Pharmacy ; (12): 406-412, 2021.
Article in Chinese | WPRIM | ID: wpr-873479

ABSTRACT

OBJECTIVE:To provide reference for constructing and improving the pharmacovigilance signal management sys - tem in China by comparing signal management system among the European Union (EU),the United States (U. S. )and Japan. METHODS:Literature analysis method was used to systematically compare the similarities and differences on definitions ,sources, detection methods and management process of pharmacovigilance signals among EU ,U. S. and Japan. Some suggestions were put forward for pharmacovigilance management in China. RESULTS & CONCLUSIONS :Regulatory authorities of the EU ,U. S. and Japan did not have a uniform definition on signals ;EU drug administration adopted the definition of the eighth working group of Council for International Organizations of Medical Sciences ,FDA adopted its own definition ,while the Japanese regulatory agency had no clear definition. Currently ,post-marketing surveillance still relied mainly on spontaneous reporting systems ;EU,U. S. and Japan had carried out the signal detection based on the spontaneous reporting system ;EU mainly adopted the proportional reporting ratio method ,U. S. mainly adopts the multiple gamma Poisson Shrinker ,and Japan mainly adopted the reporting ratio method. EU had special guidelines for signal management process ,while the U. S. and Japan did not. It is recommended to accelerate the deve- lopment of the legal and regulatory framework on pharmacovigilance in China ,draw up guidelines on pharmacovigilance practices , strengthen the active ADR surveillance and promote the application of data mining techniques in signal detection field ,for accelerat - ing the standardization and internationalization of China ’s pharmacovigilance work.

11.
Cad. pesqui ; 50(175): 78-94, enero-mar. 2020. tab
Article in English | LILACS-Express | LILACS, INDEXPSI | ID: biblio-1132909

ABSTRACT

Abstract This article aims to analyze the school days in European Union countries, systematizing similarities and differences between education systems. The compared analysis involved fifteen member countries and focused on the descriptive and comparative phases of the classical comparative method. School days are socio-historical and cultural constructions, which result in sometimes convergent, sometimes divergent policies in the region. In general, the compulsory school day in European countries is from 5 to 6 hours per day. However, there are many features, including investment in policies that integrate curricular and extracurricular activities, as supervised socio-educational times. Through compared analysis, it was possible to identify perspectives and alternatives to the school day configuration to better answer to the demands and needs of the subjects of education.


Résumé Cet article vise à analyser la durée de la journée scolaire des pays de l'Union européenne et systematiser les similitudes et les différences entre les systèmes éducatifs. L'analyse comparée a porté sur quinze pays membres et s'est concentrée sur les phases descriptive et comparative de la méthode comparative classique. Les journées scolaires sont des constructions socio-historiques et culturelles, qui entrainent des politiques tantot convergentes, tantot divergentes dans la région. En général, la journée scolaire obligatoire dans les pays européens est de 5 à 6 heures par jour. Cependant, il existe de nombreuses spécificités, notamment l'investissement dans des politiques intégrant les programmes d'études, les activités parascolaires et les périodes socio-éducatives supervisées. Grâce à une analyse comparative, il a été possible d'identifier des perspectives et des alternatives à la configuration de la journée scolaire afin de mieux répondre aux demandes et aux besoins des sujets de l'éducation.


Resumen Este artículo tiene como objetivo analizar las jornadas escolares de países de la Unión Europea, sistematizando similitudes y diferencias entre los sistemas educativos. El análisis comparado involucró a quince países miembros y se centró en las fases descriptiva y comparativa del método comparativo clásico. Las jornadas escolares son construcciones sociohistóricas y culturales, que resultan en políticas a veces convergentes y otras veces divergentes en la región. En general, la jornada escolar obligatoria en los países europeos es de 5 a 6 horas al día. Sin embargo, hay muchas especificidades, entre ellas la inversión en políticas que integran actividades curriculares, extracurriculares y tiempos socioeducativos supervisados. A través del análisis comparado fue posible identificar perspectivas y alternativas a la configuración de la jornada escolar para responder mejor a las demandas y necesidades de los sujetos de la educación.


Resumo O presente artigo tem como objetivo analisar as jornadas escolares de países da União Europeia, sistematizando semelhanças e diferenças entre os sistemas educativos. A análise comparada envolveu quinze países-membros e focalizou as fases descritiva e comparativa do método comparativo clássico. As jornadas escolares são construções sócio-históricas e culturais, o que resulta em políticas ora convergentes, ora divergentes na região. De forma geral, a jornada escolar compulsória dos países europeus é de 5 a 6 horas diárias. No entanto existem muitas especificidades, entre as quais o investimento em políticas que integram atividades curriculares, extracurriculares e tempos socioeducativos supervisionados. Por meio da análise comparada foi possível identificar perspectivas e alternativas à configuração da jornada escolar para melhor responder às demandas e necessidades dos sujeitos da educação.

12.
China Pharmacy ; (12): 2817-2821, 2020.
Article in Chinese | WPRIM | ID: wpr-837532

ABSTRACT

OBJECTIVE:To provide refe rence for improving the moni toring system of simplified registration system of Chinese classical formulas. METHODS :A comparative study was conducted on the simplified registration system of traditional herbal medicines in the European Union and Chinese classical formulas from the aspects of regulatory agencies ,regulatory systems , simplified registration conditions ,simplified registration catalogs and registration data. On the basis of the experience of the simplified registration system of traditional herbal medicines in the European Union ,some suggestions were put forward to improve the simplified registration system of Chinese classical formulas. RESULTS & CONCLUSIONS :The European Union establishes special committee on traditional herbal medicine for registration and supervision ;has established a complete regulatory system from directives to specific guidelines ;focuses on the history and conditions of the use of traditional herbal medicine ;has published the European Union monographs and European Union list ,which are used as a basis for safety and effectiveness to further reduce or exempt registration data. In China ,National Medical Products Administration and the National Administration of Traditional Chinese Medicine are jointly responsible for the registration and supervision of classical formulas. At present ,the relevant documents to simplify the registration and approval have been issued ,but there is no corresponding implementation rules and guidelines. China also attaches great importance to the clinical experience of classical formulas ,and emphasizes the consistency of preparation methods and dosage forms with ancient classics. Recently ,China has published the Catalogue of Ancient Classic Formula(the First Batch ),including 100 classical formulas ,and the classic formulas in the catalogue can be exempted from relevant registration materials when applying for registration. Our country can learn from the experience of the European Union and combine the actual situation of classic formulas supervision to establish an expert committee ,focus on quality control and risk control to improve registration and supervision system ,optimize the selection conditions of classic formulas ,and explore the classic formulas monographs , to further stimulate the innovation vitality of traditional Chinese medicine industry.

13.
Braz. arch. biol. technol ; 63: e20180646, 2020. tab, graf
Article in English | LILACS | ID: biblio-1132248

ABSTRACT

Abstract: This article is about a case study based on the participation and contact with dynamized activities through action plans for the circular economy in Europe, specifically in Portugal. It aims to identify the main in-progress actions and the challenges for the diffusion of the circular economy in the Portuguese nation and draw a panorama for Brazil, transiting through different data sources, economic sectors and stakeholders. Through data triangulation, the investigative plan contemplated participatory observations in workshops, interviews with experts, documental analyses and means of communication. After going through data cross checking for validation, the content was aggregated to a strategic analysis matrix. As a result, it was possible to identify the strengths, weaknesses, opportunities and challenges associated with the growth of the circular economy in Portugal, as well as to indicate directions and possibilities in the Brazilian context. It is possible to realize, for both countries, the importance of the international benchmarking for the recognition and promotion of circular economy actions, besides the necessity to revise laws aligned with the internal e external market rules, by increasing the offer of circular products and services.


Subject(s)
Humans , Economic Development , Environmental Policy/economics , Health Governance , Portugal , Strategic Planning , Brazil , Benchmarking , Developing Countries/economics
14.
China Pharmacy ; (12): 2449-2454, 2019.
Article in Chinese | WPRIM | ID: wpr-817258

ABSTRACT

OBJECTIVE: To provide reference for the establishment and improvement of drug reevaluation system in China. METHODS: The design and relevant laws of drug reevaluation system in America, European Union and Japan were reviewed and summarized. The shortcomings of drug evaluation in China were analyzed and suggestions for improvement were put forward. RESULTS & CONCLUSIONS: America, European Union and Japan have formulated relevant laws and systems for post-marketing reappraisal of drugs, as well as specific implementation norms and technical support plans. The legal system of drug reevaluation in America can be divided into ADR monitoring and reporting system, post-marketing drug research system and active drug safety risk monitoring system. The European Union mainly has a monitoring and evaluation system for conventionally marketed drugs, drugs licensed under exceptional circumstances or conditions, and a re-registration system for drugs. Japan’s legal system of reevaluation mainly consists of reexamination system, reevaluation system and other systems. However, there are still some shortcomings in the drug reevaluation in our country, such as weak system, weak legislation, inadequate operability and deterrence, ineffective links between the implementation and application of drug evaluation results, and ineffective allocation of resources. It is suggested that we should integrate the existing reevaluation system to improve the legal system of drug reevaluation in China,starting from the systematic construction of the legal system of drug reevaluation, the construction and standardization of the legislative level, the connection of the legal system of drug reevaluation and the allocation of resources.

15.
China Pharmacy ; (12): 443-447, 2019.
Article in Chinese | WPRIM | ID: wpr-817084

ABSTRACT

OBJECTIVE: To provide reference for in-depth reform of new drug assessment and approval system in China. METHODS: The legal basis of drug accelerated assessment policies in European Union (EU) were analyzed systematically, and then compared with other similar policies. The key steps of accelerated assessment procedure were introduced, in particular, pre-submission preparation, pre-licensing inspection, submission and evaluation of accelerated assessment application. Taking Maviret as an example, the effects of EU’s accelerated assessment policies were analyzed empirically. RESULTS: Accelerated assessment is one of the EU’s several legal provisions to foster patients’ early access to new drugs, as well as accelerated assessment and conditional market licensing, sympathetic drug use, priority drug program, orphan drug identification and hospital exemption, which were the main ways to obtain new drugs as soon as possible in the EU. The accelerated assessment was expected when the drugs had sufficient treatment data, significant public health benefits and innovation. Based on EU’s regulations (No. 726/2004/EC), European Medicines Agency (EMA) had continuously improved the policy system of accelerated assessment, issued relevant guiding principle (guidelines) and timetables for the implementation of accelerated assessment procedures, providing detailed and specific guidance for the practical landing of the policy. Once the drug entered the accelerated assessment procedure, the assessment time would be shortened from 210 days of the standard procedure to 150 days. The assessment of Maviret, a new drug for the treatment of hepatitis C virus infection, was accelerated from Jan. 20, 2017 until Jun. 22, 2017. When it was approved by the EMA Committee for Human Medicinal Products (CHMP), the whole process was less than half a year. CONCLUSIONS: EU drug acceleration assessment has not only perfect legislative support, but also detailed and specific implementation rules and timetable. It can speed up the marketing of drugs which are required urgently by the public and have speeific medical advantages.

16.
Chinese Pharmaceutical Journal ; (24): 1895-1900, 2019.
Article in Chinese | WPRIM | ID: wpr-857859

ABSTRACT

OBJECTIVE: The supervision of biosimilars in EU is based on scientific and reasonable principles. It not only had lots of laws, regulations and policy guidelines on marketing approval, but also made great efforts in clinical use and risk monitoring. To provide reference for the supervision and management of biosimilars in China. METHODS: Through the data summary and system comparison, the article described and analyzed the clinical use incentives and post-marketing risk control policies of biosimilars in EU countries. RESULTS: It is found that under the background of perfecting the regulatory systems and policies, EU countries encourage the vigorous development of the biosimilar industry and strictly control the drugs' safety, effectiveness and clinical risks. CONCLUSION: China could learn from the EU experience, encourage the development of biosimilars by improving pricing, reimbursement, clinical substitution and other policies. At the same time, we should also pay attention to the specificity of biosimilars, ensure that clinical risks are controllable and drugs are safe and effective.

17.
Rev. bras. psicanál ; 52(4): 75-94, out.-dez. 2018. ilus
Article in Portuguese | LILACS-Express | LILACS, INDEXPSI | ID: biblio-1288774

ABSTRACT

O autor acompanha o amor na obra de Freud, desde uma carta a Jung, de 1906, em que Freud defende com convicção que o amor é o fator essencial na cura psicanalítica. Green diz que todas as correntes concordam com isso até hoje. Do amor individual passamos ao amor da psicologia das massas e, daí, vislumbramos a diminuição da violência e também das guerras no mundo, que se expressa com a longa paz entre as grandes nações, de 1945 até hoje. Para que isso seja possível, o amor tem que estar presente, embora saibamos que os perigos da bomba estejam muito vivos e sejam ameaçadores. Os pontos de vista divergentes de Steven Pinker e John Gray também são considerados. Os europeus criaram uma utopia que se tornou realidade: a União Europeia. Ela se constituiu através de um extraordinário perdão desses povos, fator que permitiu ao Ocidente viver o melhor dos mundos, em termos relativos, até hoje. Habermas defende ardorosamente a universalização dos direitos humanos, mas reconhece que, para realizar tal objetivo, esses direitos dependem de sua incorporação institucional numa sociedade mundial constituída politicamente.


The author has followed Love in Freud's work since the letter to Jung (1906) in which Freud defended with conviction that Love was the essential factor of psychoanalytic healing. To this day, all theories agree, Green says. From individual love, we go through the love of the Psychology of the Masses and, then, we may observe the decrease of violence and wars in the world, which has been expressed by the Long Peace between the Great Nations since 1945. It will only be possible if Love is present, even though we are aware of the dangers of the BOMB, still very alive and threatening. The divergent views of S. Pinker and John Gray are considered in this work. Europeans have created a Utopia that has come true - the European Union. It was constituted through an extraordinary pardon by these people, a factor that so far has enabled the Western world to live The Best of the Worlds, in relative terms. Although Habermas ardently defends the universalization of human rights, he recognizes that, to achieve this goal, these rights “depend on their institutional incorporation into a politically constituted world society.”


El autor acompaña el Amor en la obra de Freud desde la carta a Jung de 1906, cuando Freud defendía con convicción que el Amor era el factor esencial en la cura psicoanalítica. Green dice que todas las corrientes concuerdan con esto hasta hoy. Del amor individual pasamos al amor de la psicología de las masas y, de ahí, podemos vislumbrar la disminución de la violencia y también de las guerras en el mundo, que se expresan en la Larga Paz entre las Grandes Naciones desde 1945 hasta hoy. Para que esto sea posible el Amor tendrá que estar presente aunque seamos conscientes de que los peligros de la BOMBA están muy vivos y amenazadores. Los puntos de vista divergentes, de S. Pinker y de John Gray, también son considerados. Los europeos crearon una Utopía que se hizo realidad - la Unión Europea. Ella se constituyó a través de un extraordinario perdón de estos pueblos, perdón que permitió al mundo occidental vivir Lo Mejor de los Mundos, en términos relativos, hasta hoy. Habermas defiende ardorosamente la universalización de los derechos humanos, pero reconoce que para lograr tal objetivo estos derechos “dependen de su incorporación institucional en una sociedad mundial constituida políticamente”.


L'auteur suit l´amour dans l'ouvrage de Freud depuis la lettre à Jung en 1906, où Freud défendait avec conviction que l'amour était le facteur essentiel pour la guérison psychanalytique. Green dit que tous les courants sont d'accord avec Freud jusqu'à aujourd'hui. De l'amour individuelle, on passe par l'amour de la psychologie des masses et, ainsi, on peut apercevoir la diminution de la violence, aussi bien que celle des guerres dans le monde, ce qui est exprimé avec La Longue PaIX entre les Grands Pays depuis 1945 jusqu'aujourd'hui. Pour que ceci soit possible l'amour devrait être présent, même si nous savons que les dangers issus d'une Bombe sont encore très présents et terrifiants. Les points de vue divergents de S. Pinker et de John Gray sont aussi considérés. Les Européens ont créé une utopie qui est devenue réalité: l'Union Européenne. Celle-ci s'est constitué au moyen d'un extraordinaire pardon de ces peuples, pardon qui a permis au monde occidental de vivre “le meilleur des mondes”, en termes relatifs, jusqu'à présent. Habermas défend avec ardeur l'universalisation des droits de l´homme, mais il reconnait que, pour mener à bien un tel objectif, ces droits “dépendent de son incorporation institutionnelle dans une société mondiale constituée politiquement”.

18.
Ciênc. Saúde Colet. (Impr.) ; 23(7): 2253-2264, jul. 2018. tab
Article in Portuguese | LILACS | ID: biblio-952692

ABSTRACT

Resumo Sob o efeito do Memorando da Troika (2011-2015), as políticas de saúde em Portugal conhecem uma agenda política, empresarial e organizacional orientada por princípios de privatização, desregulação e subfinanciamento dos serviços públicos por parte do Estado. Neste artigo, faz-se uma revisão da literatura sobre os sistemas de saúde dos países do Sul, destacando-se a situação portuguesa quanto aos processos de reforma e principais desigualdades de saúde antes e durante a crise econômica. Complementarmente, convocam-se os testemunhos de diferentes profissionais do setor da saúde (médico, enfermeiro, técnico de terapêutica, sindicatos e dirigentes de unidades de cuidados). Baseado num estudo exploratório, discutem-se as transformações político-organizacionais e suas consequências na desregulação e precarização das relações de trabalho no setor da saúde. Reduções salariais, congelamento de carreira, instabilidade contratual, desmotivação profissional, intensificação do ritmo de trabalho e desqualificação dos serviços são alguns dos sinais mais visíveis de uma agenda gestionária que conflitua com as missões de um Sistema de Saúde Pública (SNS) universal ao serviço da sociedade portuguesa.


Abstract Under the Troika Memorandum (2011-2015), health policies in Portugal know a political agenda, business and organizational schedule guided by the principles of privatisation, deregulation and underfinancing of public services by the State. In this article, the authors provide a review of the literature on health systems in the countries of the Southern European countries, highlighting the Portuguese situation regarding reform processes and major health inequalities before and during the economic crisis. Complementarily, the testimonies of different professionals of the health sector (doctor, nurse, therapeutics technician, unions and heads of care units) are summoned. Based on an exploratory study, it is our purpose to discuss political-organisational transformations and their consequences in the deregulation and precariousness of labour relations in the health sector. Wage reductions, career freeze, contractual instability, professional demotivation, intensification of the work pace and disqualification of services are some of the most visible signs of a management agenda that conflicts with the missions of a universal National Health System (NHS) at the service of Portuguese society.


Subject(s)
Humans , Politics , Delivery of Health Care/organization & administration , Health Policy , National Health Programs/organization & administration , Portugal , Health Personnel/legislation & jurisprudence , Health Personnel/organization & administration , Delivery of Health Care/legislation & jurisprudence , Health Status Disparities , Europe
19.
Rev. méd. Chile ; 146(5): 636-642, mayo 2018.
Article in Spanish | LILACS | ID: biblio-961440

ABSTRACT

Qualification of learning outcomes in terms of knowledge, skills, responsibility and autonomy provided by medical specialist programs is of interest to State authorities, educational service providers, employers, and specialists. Countries that are signatories to the Bologna Process and others outside Europe, established that the guaranteed primary degree for medical studies is the Master in Medicine (second cycle). There is agreement that medical specialist programs are more advanced than a Master of Medicine but are different from the Doctor of Medicine (third cycle) in their clinical orientation. These programs usually do not have research components and occasionally they are not carried out in the higher education system. However, the level of qualification of medical specialist programs has not been established due to lack of consensus. In Chile, this decision becomes even more complicated due to the certification of "licenciatura" (first cycle) that medical schools provide. There are also gaps in the educational classification procedure employed by the country. However, the review of national qualification frameworks and government acts shows that some countries have validated these certifications as third cycle. Medical specialties certainly do not correspond to PhD programs and the eligibility of the qualification level must be guaranteed to all stakeholders, who require an agreement on the specific national framework of learning outcomes and competencies.


Subject(s)
Humans , Specialization/standards , Certification , Clinical Competence/standards , Curriculum/standards , Education, Medical, Graduate/standards , Chile
20.
Dados rev. ciênc. sociais ; 61(1): 47-76, jan.-mar. 2018. tab
Article in Portuguese | LILACS | ID: biblio-890995

ABSTRACT

RESUMO Embora o mercado único da União Europeia (UE) pressuponha a inexistência de barreiras nas trocas intracomunitárias, estas barreiras persistem configurando infrações à livre circulação de bens entre Estados membros. O argumento central deste artigo é que os governos dos países da UE tendem a aceitar infringir a liberdade de circulação e a manter o status quo protecionista em setores em que os grupos de interesse econômico são mais influentes. Com base na análise estatística de duas bases de dados disponibilizadas pela Comissão Europeia, o artigo evidencia a prevalência destas infrações protecionistas na UE e analisa, em especial, como a proteção nacional é mais frequente em setores com maior capacidade de pressão, nomeadamente no setor agrícola. A experiência europeia revela-se útil para outros projetos de integração na medida em que evidencia a possibilidade de ocorrerem pressões protecionistas de grupos econômicos que resultam em violações persistentes às regras dos acordos, e mostra a necessidade de esforços contínuos por parte das instituições regionais de se oporem a esse incumprimento.


ABSTRACT Although the single market of the European Union (EU) supposes the inexistence of barriers in intracommunity trade, such barriers persist, hindering the free circulation of goods between the member states. The main argument proposed in this article is that governments of EU countries tend to accept infringements on freedom of circulation and to maintain the protectionist status quo in sectors in which groups of economic interest are most influential. Based on a statistical analysis of two databases made available by the European Commission, the article highlights the prevalence of such protectionist infractions in the EU, with a particular analysis made on how national protection is more frequent in sectors with a greater capacity for pressure, namely in the agricultural sector. The European experience is a useful comparison point for other integration projects in so far as it reveals how protectionist pressures from economic groups can lead to persistent violations of the regulations in agreements, demonstrating the need for continuous efforts by regional institutions to oppose such non-compliance.


RÉSUMÉ Bien que le Marché unique de l'Union européenne (UE) présuppose l'inexistence de barrières pour les échanges intracommunautaires, certaines d'entre elles persistent néanmoins, en infraction à la libre circulation des biens entre les États membres. L'argument central de cet article est que les gouvernements des pays de l'Union européenne tendent à accepter ces infractions à la liberté de circulation et à maintenir le statu quo protectionniste dans les secteurs où les groupes d'intérêts économiques sont les plus influents. Sur la base de l'analyse statistique de deux banques de données mises à disposition par la Commission européenne, l'article mettra en évidence la prévalence de ces infractions protectionnistes dans l'Union européenne et analysera en particulier de quelle manière la protection nationale est plus fréquente dans des secteurs disposant d'une plus grande capacité de pression, notamment le secteur agricole. L'expérience européenne s'avère utile pour d'autres projets d'intégration dans la mesure où elle met en évidence la possibilité de la survenance de pressions protectionnistes de la part de certains groupes économiques, qui peuvent parfois mener à des infractions persistantes aux règles des accords. Cela met bien évidemment en évidence la nécessité d'efforts continus de la part des institutions régionales pour s'opposer à ses infractions.


RESUMEN A pesar de que el mercado único de la Unión Europea (UE) presupone la inexistencia de barreras en los intercambios intracomunitarios, estos obstáculos persisten y motivan quebrantamientos de la libre circulación de bienes entre Estados miembros. El argumento central de este artículo es que los gobiernos de los países de la UE tienden a aceptar infringir la libertad de circulación y a mantener el status quo proteccionista en sectores en los que los grupos de interés económico son más influyentes. Apoyándose en el análisis estadístico de dos bases de dados facilitadas por la Comisión Europea, el artículo muestra la prevalencia de estas infracciones proteccionistas en la UE y analiza, en especial, en qué medida la protección nacional es más frecuente en sectores con mayor capacidad de presión, en concreto, en el sector agrícola. La experiencia europea se revela útil para otros proyectos de integración, dado que refleja la posibilidad de que se produzcan presiones proteccionistas de grupos económicos que deriven en violaciones persistentes de las reglas de los acuerdos, y muestra la necesidad de que las instituciones regionales se esfuercen constantemente por oponerse a este incumplimiento.


Subject(s)
Politics , Economics , Europe
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