LRQA @Raps 2016
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Struggling to understand the new EU MDR and IVDR? Join Theresa Jeary, Technical Services Manager Medical Devices Certification, LRQA Medical Directives Team, as she shares her view on the key changes. www.lrqausa.com | www.lrqa.com.br | www.lrqamexico.com
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– El Rol de la Norma ISO 17021
– El Rol de las Normas de Inocuidad de los Alimentos y los Propietarios de Esquemas (por ejemplo: FSSC 22000)
– El Enfoque del Organismo de Certificación
– El Rol de la GFSI
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There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
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Novas diretrizes da OMS para os cuidados perinatais de mais qualidadeProf. Marcus Renato de Carvalho
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
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Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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LRQA @Raps 2016
- 1. Improving performance, reducing risk New EU MDR and IVDR: Understanding Key Changes, Impacts and Actions Tuesday, Sept 20 at 2:45 – Exhibit Hall Join this session for an understanding of the key changes, impacts, transition phase and key steps to be taken around this new EU MDR/IVDR Medical Device Law. Don’t miss these sessions at: Join Theresa Jeary, Technical Services Manager Medical Devices Certification, LRQA Medical Directives Team, as she shares her view on the key changes. Understanding ISO 13485:2016 – Risk Management Implications and Interconnection with Other Regulatory Requirements Tuesday, Sept 20 at 3:30 – Room LL21 C/D Find out what’s new and what has changed and the impact it will have on your organization. Tuesday, Sept 20 at 2:45 • Exhibit Hall Struggling to understand the new EU MDR and IVDR? Visit LRQA at Stand #225 for a chance to win an Amazon Echo® or a Fit Bit Blaze® !