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The Seventy-first World Health Assembly

The World Health Assembly The World Health Assembly (WHA) is the decision-making body of WHO.  It is attended by delegations from all WHO Member States and focuses on a specific health agenda prepared by the Executive Board.

The main functions of the World Health Assembly are to determine the policies of the Organization, supervise financial policies, and review and approve the proposed programme budget.

This year’s Health Assembly takes place on 21–26 May 2018 in Geneva, Switzerland.

Live at http://www.who.int/world-health-assembly/seventy-first

Following the WHA at http://www.who.int/world-health-assembly/seventy-first/social-good

 World Health +SocialGood: Show schedule

Tuesday, 22 May

Bringing health to all

  • Universal health coverage: what it means and how we can achieve it
  • HIV/AIDS: achievements and challenges
  • Smallpox: the story of eradication

Wednesday, 23 May

Keeping healthy in today’s world

  • Air pollution
  • Transfats
  • Assistive technologies
  • Maternal, child and adolescent health

Thursday, 24 May

Keeping the world safe, serving the vulnerable

  • Ebola in the Democratic Republic of Congo
  • Cox’s Bazar
  • Vaccination to prevent and contain outbreaks
  • EPI: the early days
  • Influenza: prevention and control

For more information about the Seventy-first WHA, go to http://www.who.int/world-health-assembly/seventy-first

 
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COFEPRIS: 10.1 millones de dispositivos médicos irregulares asegurados

El Comisionado Federal para la Protección contra Riesgos Sanitarios, Julio Sánchez y Tépoz, informó que en lo que va de la presente administración federal, la COFEPRIS ha asegurado 10.1 millones de dispositivos médicos irregulares y decomisado más 335 toneladas de medicamentos irregulares.

Más informaciones por el enlace: https://www.gob.mx/cofepris/articulos/10-1-millones-de-dispositivos-medicos-irregulares-asegurados-cofepris-157511?idiom=es

 
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FDA approves novel preventive treatment for migraine

For Immediate Release

May 17, 2018

The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.

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For more information go to https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm

 
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ANMAT: Llamado a Concurso de Beca de investigación en Ciencia Reguladora

La Administración Nacional de Medicamentos, Alimentos y Tecnología Médica convoca a concurso para el otorgamiento de una beca en el marco del programa “Becas de Investigación en Ciencia Reguladora” aprobado por Disposición ANMAT 10451/17, sobre “Obtención y evaluación preclínica de nanovehículos farmacéuticos para aplicación en el tratamiento de la enfermedad de Chagas”.

Más informaciones por el enlace http://www.anmat.gov.ar/comunicados/Llamado_a_Concurso_Beca_5-18.pdf

 
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FDA MedWatch – Keytruda (pembrolizumab) or Tecentriq (atezolizumab): Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

MedWatch – The FDA Safety Information and Adverse Event Reporting Program
A new MedWatch Safety Alert: Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement – Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy  intended for: Oncology, Pharmacy, Risk Manager was just added to the FDA MedWatch Webpage.

You can read the complete MedWatch Safety Alert that includes recommendations at: https://go.usa.gov/xQPtf

 
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Report: World health statistics 2018: monitoring health for the SDGs, sustainable development goals

Source: World health statistics 2018: monitoring health for the SDGs, sustainable development goals. Geneva: World Health Organization; 2018. CC BY-NC-SA 3.0 IGO.

ISBN: 978-92-4-156558-5

 Published online: May 2018

The World Health Statistics series is WHO’s annual snapshot of the state of the world’s health. This 2018 edition contains the latest available data for 36 health-related Sustainable Development Goal (SDG) indicators. It also links to the three SDG-aligned strategic priorities of the WHO’s 13th General Programme of Work: achieving universal health coverage, addressing health emergencies and promoting healthier populations.

The latest data show that:

:: Less than half the people in the world today get all of the essential health services they need.

:: In 2010, almost 100 million people were pushed into extreme poverty because they had to pay for health services out of their own pockets.

:: 13 million people die every year before the age of 70 from cardiovascular disease, chronic respiratory disease, diabetes and cancer – most in low and middle-income countries.

:: Every day in 2016, 15 000 children died before reaching their fifth birthday.

:: 303 000 women died due to complications of pregnancy or childbirth in 2015. Almost all of these deaths occurred in low- and middle-income countries (99%). Reducing maternal mortality crucially depends upon ensuring that women have access to quality care before, during and after childbirth.

For details and additional information / Más información y material adicional click here.

Full report / Informe completo click here.

 
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Fabricantes de medicamentos colombianos recebem o primeiro certificado de Boas Práticas de Fabricação pela ANVISA sem necessidade de visita presencial.

A Agência Nacional de Vigilância Sanitária do Brasil (Anvisa) certificou pela primeira vez em Boas Práticas de Fabricação (BPF) dois laboratórios farmacêuticas colombianos sem a realização de visita, que se baseia exclusivamente em relatórios de inspeção do Instituto Nacional de Vigilância de Medicamentos e Alimentos (Invima).

Os laboratórios certificados são: Procaps S.A (Barranquilla) e Eurofarma Colombia S.A.S. (Bogotá).

Esta importante conquista é obtida através do reconhecimento de nível que Invima ganhou por ser uma Autoridade Nacional Reguladora de Referência Regional (ARNr) de nível pela Organização Panamericana de Saúde (OPAS), indicando que a agência tem metodologias uniformes e transparentes para o cumprimento de suas funções de controle e controle, eficiência, garantindo, segurança e qualidade dos medicamentos. De igual maneira, ANVISA também é reconhecida como uma das oito ARNr.

Fonte: https://www.invima.gov.co/primeros-laboratorios-farmac%C3%A9uticos-colombianos-certificados-en-bpm-por-anvisa-sin-visita.html

 
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FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings

05-16-2018 Update

In addition to approving the updated prescribing information concerning the gadolinium retention safety issues described in the Drug Safety Communication below, FDA has also approved new patient Medication Guides for all GBCAs.

Health care professionals and patients can access the patient Medication Guides according to the GBCA drug name* on the Medication Guides webpage, or the latest prescribing information by searching in Drugs@FDA.

All MRI centers should provide a Medication Guide the first time an outpatient receives a GBCA injection or when the information is substantially changed. In general, hospital inpatients are not required to receive a Medication Guide unless the patient or caregiver requests it. A health care professional who determines that it is not in a patient’s best interest to receive a Medication Guide because of significant concerns about its effects may direct that it not be provided to that patient; however, the Medication Guide should be provided to any patient who requests the information.

*The brand names of the GBCAs can be found in Table 1 below.
For more information on distribution of Medication Guides, see the Guidance Document, the Drug Info Rounds Video, or the Code of Federal Regulations at 21 CFR 208.26.

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For more information go to https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm