Save the date! Our 6th ISoP–UMC pharmacovigilance course takes place in Guayaquil, Ecuador in September, 24 – 26, 2018. More information will be made available and the registration will open soon.
If you have any questions please contact administration@isoponline.org.
26 de febrero 2018.
En el año 2017 en Costa Rica se realizaron 495 trasplantes, de estos, 120 trasplantes fueron de órganos, 297 de córneas y 78 trasplantes de médula ósea.
Más informaciones por el enlace https://www.ministeriodesalud.go.cr/index.php/noticias/noticias-2018/1280-120-trasplantes-de-organos-se-realizaron-en-el-pais-en-el-2017
Se trata del Lote X910915 del producto, que cuenta con Notificación Sanitaria Obligatoria colombiana No. INVIMA NSOC63380-14CO, del titular Comercio Cosval S.A.S y fabricado por Samara Cosmetics S.A.S.
Invima solicitó detener el uso del lote descrito, debido al resultado no conforme asociado con alteración de la calidad microbiológica, indicando a la comunidad en general que suspenda de inmediato su uso, debido a los riesgos que puede representar para su salud.
Ante esta información, Arcsa recomienda a la ciudadanía no comercializar, distribuir ni utilizar el producto “CHAMPÚ COSVAL SALUD Y BELLEZA”; cabe indicar que el producto no cuenta con la Notificación Sanitaria Obligatoria Ecuatoriana y por ello, al no poder garantizar su calidad, seguridad y eficacia, representa un riesgo para la salud de la población.
Arcsa invita a la ciudadanía a informar sobre la venta o distribución de productos sin Registro Sanitario y/o Notificación Sanitaria, o de dudosa procedencia, así como cualquier reacción adversa relacionada con algún producto de uso y consumo humano, a través del correo electrónico: farmaco.vigilancia@controlsanitario.gob.ec o mediante la aplicación “Arcsa Móvil”. Sus datos personales y la información brindada serán absolutamente confidenciales.
February 26, 2018
The current influenza season has been especially difficult, causing widespread illness that has affected all fifty states and resulted in a record number of hospitalizations. While healthcare professionals continue to combat this year’s flu – which may continue to affect Americans into April – we’re already partnering with other public health agencies to conduct essential work to produce next season’s influenza vaccines.
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For more information go to https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm598317.htm
FDA released a guidance for industry entitled “Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers.” This guidance is intended to provide clarification to the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance document “Q11 Development and Manufacture of Drug Substances” to improve harmonization and promote convergence for information that should be provided in marketing authorization applications and Master
Source: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM542176.pdf
[Original in Portuguese]
The event, which will deal with Clinical Assessment of Medical Devices, will take place at the Agency’s headquarters on March 27th.
On March 27, Anvisa will host the workshop on Clinical Evaluation of Medical Devices. The event, which will begin at 9:00 am in the auditorium of the Agency, counts on the partnership of the Brazilian Association of the Industry of Articles and Medical, Dental, Hospital and Laboratories (Abimo), Brazilian Association of the High Technology Product Industry for Health (Abimed) and the Brazilian Association of Importers and Distributors of Health Products (Abraidi).
The workshop aims to disseminate knowledge and improve processes and practices through the sharing of national and international experiences and the identification of difficulties and challenges related to the theme.
For more information go to http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4085408
[Original text in Spanish]
The National Standardization Office (ONN) has just approved the national standard ISO ISO 13485: 2018. Medical equipment and devices. Quality Management Systems. Requirements for regulatory purposes.
This is a result of the work done by the specialists of the Department of Equipment and Medical Devices since 2016 when the international standard was approved. Multiple actions framed in a national research project were carried out, ranging from the study of new requirements, comparison with previous editions of the standard, training to manufacturers, importers, distributors and suppliers of medical equipment and devices, the updating of the regulatory requirements for quality management systems, and the preparation and presentation to the Technical Committee for Standardization # 11 of medical equipment of the draft of the new Cuban standard.
The ANMAT informs the professionals that it has been ordered by Disposition ANMAT N ° 337-E / 2018 the start of the recall of all the current lots of injectable products prepared by LEMAX LABORATORIOS S.R.L. in the plant located in Neuquén 623, Lomas del Mirador, province of Buenos Aires, with expiration date until January 2020 inclusive.
The measure was adopted as a result of an inspection carried out at the establishment, during which critical breaches were detected and greater than the Good Manufacturing Practices and Control regulations during the preparation of the lots. This National Administration is monitoring the recall from the market and recommends that professionals abstain from using these products.
Source: http://www.anmat.gov.ar/comunicados/Retiro_del_mercado_LEMAX_21-2-18.pdf
The Ministry of Health of Belize has release a list of the most updated 2017 list of retail pharmaceutical establishments with a valid Ministry of Health facility License: Go to 2017 list to access copy
April 30 – May 1, 2018
The Global Cancer Clinical Research, Drug Development and Therapeutic Accessibility Workshop is a collaborative effort between the Duke University Center for Applied Therapeutics and the National Cancer Institute’s Center for Global Health.
The availability of new cancer treatments varies widely around the world. This workshop will focus on the clinical testing and development, regulatory approval, and access to/reimbursement for anticancer drug activity that occurs internationally. It will deal with the complex issues specific to international oncology drug development, focusing on molecular subtypes of cancer, rare cancers and pediatric cancers.
The Workshop aims to develop research networks to facilitate collaboration and increase efforts to reduce the global burden of cancer.
For more information go to https://www.globalcancerdrugdevelopment.org/
