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Naciones Unidas premió al Laboratorio de Hemoderivados de la UNC

El Laboratorio de Hemoderivados de la UNC fue galardonado con el Premio al Servicio Público de Excelencia que otorga la Organización de la Naciones Unidas.  Este premio recompensa los logros creativos y las contribuciones de las instituciones de servicio público que sostienen una administración pública más efectiva y receptiva en los países de todo el mundo. A través de una competencia anual, los Premios de Servicio Público de la ONU promueven el rol, la profesionalidad y la visibilidad del servicio público.

Hemoderivados ganó en la categoría 2 del premio, “Garantizando enfoques integrados en las instituciones del sector público”, que destaca el desempeño de la institución universitaria como modelo de negocio social, sinérgico y sustentable; orientado a la producción pública de medicamentos para garantizar su disponibilidad y acceso a la población de Argentina y de países de América Latina.

 

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Más informaciones por el enlace https://www.unc.edu.ar/comunicación/naciones-unidas-premió-al-laboratorio-de-hemoderivados-de-la-unc 

 
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WHO PUBLIC CONSULTATION: Working document QAS/19.808 – Concept Note: A Framework for Evaluating and Publicly Designating Regulatory Authorities as WHO-Listed Authorities: Request for comments by 17 July 2019

WHO published a Concept Note entitled “A FRAMEWORK FOR EVALUATING AND PUBLICLY DESIGNATING REGULATORY AUTHORITIES AS WHO-LISTED AUTHORITIES”, which will be posted on the WHO Medicines website under Current Projects for public revision and comments  (https://www.who.int/medicines/areas/quality_safety/quality_assurance/qas19_808_WHO_listed_authorities.pdf?ua=1).

This Concept Note presents a proposed definition for WHO-Listed Authorities (WLAs); procedures for designating a WLA; and the process for finalizing the definition and the procedures for putting the framework into place.

Given the wide interest in and implications associated with the definition and framework, WHO will adopt a multi-prong consultation process as outlined in this Concept Note.  Further details will be announced in due course.

All comments received by 17 July 2019 will be considered in the preparation of a draft policy and draft operational guidance documents. Please send any comments you may have to nra_admin@who.int , with a copy to Ms Claire Vogel (vogelc@who.int).

 
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Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada

March 19, 2019
Our file number: 19-101967-390

Under the Regulatory Review of Drugs and Devices initiative, Health Canada is increasing the efficiency of the regulatory system and supporting timely access to therapeutic products. As part of this initiative, Health Canada is pleased to announce the launch of the e-Learning tool, Understanding How Medical Devices are Regulated in Canada – Premarket Regulation.

This web-based tool, designed as an interactive learning platform, offers an overview of Health Canada’s premarket regulatory requirements for medical devices. It also provides targeted guidance to enable greater consistency in the understanding, interpretation and application of the Food and Drugs Act, the Medical Devices Regulations and their related policies and guidelines.

The tool serves as a valuable, comprehensive, and organized source of premarket regulatory information for various medical device stakeholder groups, including manufacturers, importers, distributors, consultants, healthcare groups, and academia. By providing e-Learning content to  manufacturers and other relevant stakeholders, it is expected that the completeness and quality of Medical Device Licence applications will improve, thereby resulting in more positive, and more timely, regulatory decisions.

Health Canada encourages and invites stakeholders to utilize and benefit from this new educational tool.

Questions or concerns regarding this notice or the e-Learning tool should be directed to the Medical Devices Bureau at hc.mdb.enquiries-enquetes.bmm.sc@canada.ca.

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-e-learning.html

 
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29 Marzo – Webinar RedETSA – Modelo Web de Análisis de Impacto Presupuestario

Nos complace compartir invitación al programa de webinars de la Red de Evaluación de Tecnologías en Salud de las Américas (RedETSA) el día 29 de marzo a las 11am (EST), en la cual el Lic. Alfredo Palacios, del Instituto de Efectividad Clínica y Sanitaria (IECS) hará una presentación sobre “Modelo web de análisis de impacto presupuestario”.

El link de WebEx que utilizaremos es el siguiente: https://goo.gl/Rxrxki

 
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Chile: Presencia de partículas Cloxinato de Lisina Solución inyectable 100 mg/2 ml

Alerta Farmacéutica 2/19 – Retiro del Mercado

Clonixinato de Lisina Solución Inyectable 100mg/2 mL. (analgésico, antiinflamatorio no esteroidal (Aines)

Serie 75MH1541 – 75ML2081.

Fecha de vencimiento: 08/2021 – 11/2021

Fabricante: Laboratorio Sanderson S.A/Chile

Descripción del defecto: Presencia de partículas, cuyo origen se encuentra en estudio.

más informaciones por el enlace http://www.ispch.cl/sites/default/files/comunicado/2019/02/19-02-2019%20-%20Presencia%20de%20partículas%20clonixinato%20de%20lisina…..pdf

 
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México avança na compra consolidada de vacinas e medicamentos

Foi montado uma mesa de análise para discutir a participação do México nos Fundos Rotatório e Estratégico da OPAS / OMS.

Como membro ativo das Organizações Pan-Americanas e de Saúde Mundial da OPAS / OMS, o México busca a compra direta de certas vacinas e medicamentos por meio de fundos rotário e estratégico dessa organização internacional, dos quais obteria benefícios com relação aos preços oferecidos.

Mais informações pelo link https://www.gob.mx/cofepris/articulos/mexico-avanza-en-compra-consolidada-de-vacunas-y-medicamentos-186105?idiom=es

 

 
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Statement from the Minister of Health on the Regulation of Medical Devices in Canada From: Health Canada

Statement

November 29, 2018 – Ottawa, ON – Health Canada

As Minister of Health, protecting the health and safety of Canadians is my top priority. I am deeply concerned by recent reports of serious issues Canadians have been facing with implanted medical devices.

Canada has one of the best regulatory systems in the world for medical devices. Canadians can be confident that the medical devices available in this country have met high standards for safety and efficacy. Health Canada has been taking steps to strengthen its regulation of medical devices, and I have asked that this work be accelerated.

Beyond these existing efforts, however, the Government of Canada agrees that more can be done to further strengthen the oversight of medical devices and to be more open and transparent with Canadians about Health Canada’s regulatory activities. I have directed Health Canada to bring forward an Action Plan to accelerate these efforts on a priority basis and to work with partners on behalf of Canadians.

I have asked the Department to enhance its activities in three key areas:

1. To strengthen processes for the pre-market approvals of medical devices: This will include a review of the policies and scientific requirements for the approval of higher-risk medical devices, including requirements for clinical data. I have also directed Health Canada to take action to enable more medical device research by health professionals, and expand the use of outside medical and scientific experts to advise the Department on medical device issues.

2. To enhance post-market surveillance of medical devices: Working with partners, Health Canada will take steps to improve the reporting of medical device incidents by industry, health professionals and Canadians and make these reports publicly available. The Department will propose new rules requiring that companies inform Health Canada promptly when key foreign regulators issue warnings about a device, so that we can inform Canadians more quickly. The Department will also strengthen its compliance and enforcement activities by modernizing its existing tools and increase its inspection capacity to better identify problems before they affect Canadians.

3. To make the system for medical device approvals and surveillance more transparent: Health Canada will take steps to give Canadians additional information so that they can make better informed decisions about their use of medical devices. The Department will provide summaries of regulatory decisions when it approves more complex medical devices (known as Class III and Class IV devices). Health Canada will also work to improve access to the clinical data that support our authorizations, so that health professionals can better evaluate the benefits and risks of devices for their patients.

The full details of Health Canada’s Action Plan for Medical Devices will be published in the coming weeks.

The world of medical devices is constantly evolving, and the Government of Canada is working to ensure that our regulations and guidance keep pace so that Canadians can have confidence in the medical devices that they need.

The Honourable Ginette Petitpas Taylor, P.C., M.P.

Contacts

Thierry Bélair
Office of Ginette Petitpas Taylor
Minister of Health
613-957-0200

Media Relations
Health Canada
613-957-2983
hc.media.sc@canada.ca

Source: https://www.canada.ca/en/health-canada/news/2018/11/statement-from-the-minister-of-health-on-the-regulation-of-medical-devices-in-canada.html

 
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Cofepris: Ruta consolidada, regular mejor y prohibir menos

El Comisionado Federal para la Protección contra Riesgos Sanitarios, Julio Sánchez y Tépoz, aseguró que al existir una vinculación muy clara entre la salud y el desarrollo de los países, se debe “regular mejor y prohibir menos”, en beneficio de la salud de las personas; “poblaciones fuertes y saludables hacen países más fuertes”, sostuvo.

Más informaciones por el enlace: https://www.gob.mx/cofepris/articulos/ruta-consolidada-regular-mejor-y-prohibir-menos-jsyt-183268?idiom=es

 
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PAHO Job opportunity: Advisor, Noncommunicable Diseases Management

Advisor, Noncommunicable Diseases Management

Grade: P4

Contractual Arrangement: Fixed-Term Appointment

Contract duration: Two years, first year probationary period

Primary Location: United States-Washington, D.C.

Organization: PAHO Department on Noncommunicable Diseases and Mental Health

Schedule: Full-time

 

Application Closing Date: Dec 10, 2018, 5:59:00 PM

 

Job description and application process available online:  https://careers.who.int/careersection/ex/jobdetail.ftl?job=1805658&lang=en