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18th International Conference of Drug Regulatory Authorities (ICDRA) in Dublin, Ireland

The 18th International Conference of Drug Regulatory Authorities (ICDRA) is now up and running. Please see the link: http://www.icdra2018.ie/ which contains all necessary information about the Conference as well as the registration module.

The theme of the conference is: Smart Safety surveillance: A life-cycle approach to promoting safety of medical products.

The 18th ICDRA will facilitate focused discussions on quality issues, regulatory reform and strengthening regulatory systems, safety of medical products, substandard and falsified products, access, regulation of clinical trials, regulatory collaboration, harmonization, convergence and reliance, new technologies, regulation of herbal medicines, etc. It will be held in Dublin, Ireland, on  3 – 7 September 2018.

 

 

 

 

 
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Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication – Potential Lack of Treatment (Shock) Delivery Due to Device Failure

Failure to immediately replace the device after Message Code 102 appears may result in serious patient harm or death of the patient because the device may fail to deliver therapy when needed.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592710.htm

 
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COFEPRIS se suma al Esquema de Cooperación de Inspección Farmacéutica PIC/S

2018 será un año de retos y oportunidades en materia de regulación sanitaria. La COFEPRIS impulsará una política regulatoria responsable que garantice el acceso de los mexicanos a más y mejores soluciones en salud. Se fortalecerán las acciones en materia de investigación clínica, dispositivos médicos, medicamentos innovadores, genéricos y biotecnológicos, y se trabajará para reducir la brecha del conocimiento científico  https://www.gob.mx/cofepris/prensa/mexico-inicia-2018-como-integrante-formal-de-pic-s

Fuente: https://www.gob.mx/cofepris/articulos/mexico-inicia-2018-como-integrante-formal-de-pic-s-142121?idiom=es

 
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INVIMA Alerta: Agua Estéril para Inyección Ampoulepack contaminada

Bogota , 15 enero de 2018

Alerta No. 88

Invima alerta sobre el producto: «Agua Estéril para Inyección Ampoulepack x 10 mL lote 70307 y Agua Estéril para Inyección Ampoulepack x 5 ml, lote 70243.

Más informaciones por el enlace: https://www.invima.gov.co/medicamentos-y-productos-biologicos-aler-sani/alerta-sanitaria-numero-88-agua-est%C3%A9ril-para-inyecci%C3%B3n-ampoulepack-x-10-ml-lote-70307-y-agua-est%C3%A9ril-para-inyecci%C3%B3n-ampoulepack-x-5-ml-lote-70243-pdf/download.html