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1.
Int J Qual Health Care ; 33(Supplement_1): 56-59, 2021 Jan 12.
Artigo em Inglês | MEDLINE | ID: mdl-32991730

RESUMO

BACKGROUND: The COVID-19 pandemic has exacerbated preexisting weaknesses in the global supply chain. Regional assessments by the Food and Drug Administration (FDA), European Medicines Agency (EMA), and independent consultants, have demonstrated various contributory causal factors requiring changes in policy, relationships, and incentives within the dynamic and developing networks. Human factors and ergonomics (HFE) is an approach that encourages sociotechnical systems thinking to optimize the performance of systems that involve human activity. The global supply chain can be considered such a system. However, it has neither been systematically examined from this perspective. METHODS: In 2015, the UK Chartered Institute of Ergonomics and Human Factors established the Pharmaceutical Sector Group. This unique group is open to all who work in the pharmaceutical sector at any level and in any discipline who share the vision of a pharmaceutical system that places an understanding of HFE at the heart of improving the use of healthcare products throughout their life cycles including their supply chains. RESULTS: For this complex system to work efficiently, it is paramount that we have effective coordination and integration between the different elements in the supply chain. HFE can give valuable insights and solutions for developing these complex social-technical systems effectively. CONCLUSION: By partnering with international groups such as Biophorum and Bio Supply Chain Management Alliance, we wish to stimulate discussion about how sociotechnical thinking about HFE may help develop better monitoring and investigative techniques to strengthen global supply chains.


Assuntos
Indústria Farmacêutica/organização & administração , Ergonomia/métodos , Preparações Farmacêuticas/provisão & distribução , Humanos
2.
Vaccimonitor (La Habana, Print) ; 29(3)sept.-dic. 2020. tab, graf
Artigo em Espanhol | LILACS, CUMED | ID: biblio-1139855

RESUMO

Los nuevos paradigmas de la industria farmacéutica en el siglo XXI incorporan el uso de las técnicas de gestión de la calidad, necesarias en el cumplimiento de las buenas prácticas de fabricación en el sector biotecnológico. En este caso de estudio, se aplicó la gestión de riesgo en el cambio de campaña entre los ingredientes farmacéuticos activos de futuros candidatos inmunoterapeúticos contra el cáncer, en la etapa de desarrollo tecnológico en una instalación multiproducto certificada. Las causas potenciales de mayor influencia en las fallas son: la calificación del personal de la Dirección de Desarrollo Tecnológico en los procedimientos patrones de operación de la planta, la mezcla entre los componentes y materiales no dedicados utilizados en el proceso de purificación cromatográfica, la documentación en elaboración o aprobación y el establecimiento de las técnicas analíticas en función de la etapa del proyecto. Como resultado se proponen acciones que minimizan los riesgos de la contaminación cruzada y hacen viable un adecuado cambio de campaña entre la fabricación de los inmunoterapéuticos, durante el desarrollo tecnológico en una instalación multiproducto de la industria biotecnológica(AU)


The new paradigms of the pharmaceutical industry in the 21st century introduce the use of modern quality management techniques to comply with good manufacturing practices in the biotechnological area. In this paper, it was applied the risk management for the campaign change among the process for obtaining the active pharmaceutical ingredients to future immunotherapeutic candidates at the technological development stage in a certified multi-product facility. Particularly, the training for the development personnel in the standard operating procedures of the facility, the mixture between the components and non-dedicated materials used in the chromatographic purification process, the documentation in the preparation or approval, and the establishment of analytical techniques depending on the stage of the project are the potential causes of greater influence. As a result, actions are proposed to minimize risks and carry out an adequate campaign change feasible between the manufacture of immunotherapeutics during the technological development stage in a biotechnological multi-product facility(AU)


Assuntos
Gestão de Riscos , Desenvolvimento Tecnológico , Gestão da Qualidade , Indústria Farmacêutica/organização & administração
4.
Contemp Clin Trials ; 99: 106189, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33132155

RESUMO

Starting from historic reflections, the current SARS-CoV-2 induced COVID-19 pandemic is examined from various perspectives, in terms of what it implies for the implementation of non-pharmaceutical interventions, the modeling and monitoring of the epidemic, the development of early-warning systems, the study of mortality, prevalence estimation, diagnostic and serological testing, vaccine development, and ultimately clinical trials. Emphasis is placed on how the pandemic had led to unprecedented speed in methodological and clinical development, the pitfalls thereof, but also the opportunities that it engenders for national and international collaboration, and how it has simplified and sped up procedures. We also study the impact of the pandemic on clinical trials in other indications. We note that it has placed biostatistics, epidemiology, virology, infectiology, and vaccinology, and related fields in the spotlight in an unprecedented way, implying great opportunities, but also the need to communicate effectively, often amidst controversy.


Assuntos
Pesquisa Biomédica/organização & administração , Bioestatística/métodos , Métodos Epidemiológicos , Fatores Etários , Pesquisa Biomédica/normas , /métodos , Causas de Morte , Controle de Doenças Transmissíveis/organização & administração , Desenvolvimento de Medicamentos/organização & administração , Indústria Farmacêutica/organização & administração , Determinação de Ponto Final/normas , Europa (Continente) , Comunicação em Saúde/normas , Humanos , Imunidade Coletiva/fisiologia , Modelos Teóricos , Pandemias , Prevalência , Opinião Pública , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Estações do Ano , Fatores Sexuais , Fatores de Tempo
6.
Salud Colect ; 16: e2897, 2020 10 17.
Artigo em Espanhol | MEDLINE | ID: mdl-33147400

RESUMO

Taking into account the latent threat of future pandemics, the objective of this study is to analyze - particularly with respect to medications - the sustainability of the health system, healthcare coverage, budgetary efficiency, and connections with the pharmaceutical patent system. In this context, the pharmaceutical patent system acts as a determining factor, given that promoting its existence stimulates the production of research, but in turn its existence stands in the way of rapid advancements, primarily due to the development of protective legislation concerning patents, which has largely accommodated the industry. Given that the pharmaceutical industry has managed to extend the duration of patents and avoid the incorporation of generics, our analysis focuses on the influence of pharmaceutical patents; this influence has led to reflection on the possibility of combining efforts by forging alliances between numerous companies and the public sector in order to face the challenges posed by new diseases caused by viruses that give rise to epidemics and pandemics.


Assuntos
Antivirais , Custos de Medicamentos , Indústria Farmacêutica/organização & administração , Política de Saúde , Acesso aos Serviços de Saúde/organização & administração , Patentes como Assunto , Viroses/tratamento farmacológico , Antivirais/economia , Antivirais/uso terapêutico , Medicamentos Genéricos , Saúde Global , Humanos , Pandemias , Avaliação de Programas e Projetos de Saúde , Viroses/economia , Viroses/epidemiologia , Viroses/prevenção & controle
9.
Vaccine ; 38(34): 5418-5423, 2020 07 22.
Artigo em Inglês | MEDLINE | ID: mdl-32600908

RESUMO

The World Health Organization declared the COVID-19 disease as a pandemic requiring a rapid response. Through online search, direct communication with network members and an internal survey, engagements of developing countries' vaccine manufacturers' network members in the research and development of COVID-19 vaccines and their capacities in the manufacturing, fill-finish and distribution of vaccines were assessed. Currently, 19 network members engaged in research and development of COVID-19 vaccines, using six principal technology platforms. In addition, an internal survey showed that the number of vaccines supplied collectively by 37 members, in 2018-19, was about 3.5 billion doses annually. Almost a third of network members having vaccines prequalified by the World Health Organization comply with international regulations and mechanisms to distribute vaccines across borders. The use of existing manufacturing, fill-finish and distribution capabilities can support an efficient roll-out of vaccines against COVID-19, while maintaining supply security of existing vaccines for on-going immunization programmes.


Assuntos
Pesquisa Biomédica/organização & administração , Infecções por Coronavirus , Indústria Farmacêutica/organização & administração , Cooperação Internacional , Pandemias , Pneumonia Viral , Vacinas Virais/provisão & distribução , Ensaios Clínicos como Assunto , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/prevenção & controle , Humanos , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinas Virais/imunologia , Organização Mundial da Saúde
14.
Bull World Health Organ ; 98(5): 302-303, 2020 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-32514194

RESUMO

The COVID-19 pandemic has started a race to develop new vaccines. Making sure enough is made to meet demand will require manufacturing innovation. Tatum Anderson reports.


Assuntos
Infecções por Coronavirus/prevenção & controle , Indústria Farmacêutica/organização & administração , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinas Virais , Betacoronavirus , Indústria Farmacêutica/tendências , Humanos
16.
Cancer Control ; 27(1): 1073274820922543, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32407140

RESUMO

The "war on cancer" began over 40 years ago with the signing of the National Cancer Act of 1971. Currently, complete eradication has proven possible in early stage premetastatic disease with increasingly successful early detection and surgery protocols; however, late stage metastatic disease remains invariably fatal. One of the main causes of treatment failure in metastatic disease is the ability of cancer cells to evolve resistance to currently available therapies. Evolution of resistance to control measures is a universal problem. While it may seem that the mechanisms of resistance employed by cancer cells are impossible to control, we show that many of the resistance mechanisms are mirrored in agricultural pests. In this way, we argue that measures developed in the agricultural industry to slow or prevent pesticide resistance could be adopted in clinical cancer biology to do the same. The agriculture industry recognized the problem of pesticide resistance and responded by developing and enforcing guidelines on resistance management and prevention. These guidelines, known as integrated pest management (IPM), do not encourage eradication of pests but instead strive to maintain pests, even with the presence of resistant strains, at a level that does not cause economic damage to the crops. Integrated pest management inspired management of metastatic cancer could result in the slowing or curtailing of widespread resistance to treatment, reducing overall drug usage, and increasing the survival and quality of life of patients with cancer. Using IPM principles as a foundation and shifting the goal of treatment of metastatic disease to long-term management will require close monitoring of evolving tumor populations, judicious application of currently available therapies, and development of new criteria of success.


Assuntos
Agricultura/organização & administração , Indústria Farmacêutica/organização & administração , Resistencia a Medicamentos Antineoplásicos , Neoplasias/tratamento farmacológico , Qualidade de Vida , Humanos , Planejamento de Assistência ao Paciente/organização & administração , Controle de Pragas/organização & administração
17.
Health Secur ; 18(3): 241-249, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32348165

RESUMO

The COVID-19 pandemic is a stark reminder of the heavy toll that emerging infectious diseases (EIDs) with epidemic and pandemic potential can inflict. Vaccine development, scale-up, and commercialization is a long, expensive, and risky enterprise that requires substantial upfront planning and offers no guarantee of success. EIDs are a particularly challenging target for global health preparedness, including for vaccine development. Insufficient attention has been given to challenges, lessons learned, and potential solutions to support and sustain vaccine industry engagement in vaccine development for EIDs. Drawing from lessons from the most recent Ebola epidemic in the Democratic Republic of the Congo, as well as the 2009 H1N1 influenza, 2014-2016 Ebola, and 2015-16 Zika outbreaks preceding it, we offer our perspective on challenges facing EID vaccine development and recommend additional solutions to prioritize in the near term. The 6 recommendations focus on reducing vaccine development timelines and increasing business certainty to reduce risks for companies. The global health security community has an opportunity to build on the current momentum to design a sustainable model for EID vaccines.


Assuntos
Doenças Transmissíveis Emergentes/prevenção & controle , Infecções por Coronavirus/prevenção & controle , Saúde Global , Vacinas contra Influenza/farmacologia , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Tecnologia Farmacêutica/organização & administração , Controle de Doenças Transmissíveis/organização & administração , Doenças Transmissíveis Emergentes/epidemiologia , Infecções por Coronavirus/epidemiologia , Aprovação de Drogas , Desenvolvimento de Medicamentos , Indústria Farmacêutica/organização & administração , Feminino , Humanos , Vacinas contra Influenza/administração & dosagem , Masculino , Determinação de Necessidades de Cuidados de Saúde , Pandemias/estatística & dados numéricos , Pneumonia Viral/epidemiologia , Saúde Pública , Medidas de Segurança
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