Aporte a la rutina de la trinchera asistencial donde los conocimientos se funden con las demandas de los pacientes, sus necesidades y las esperanzas de permanecer en la gracia de la SALUD.
jueves, 14 de febrero de 2019
Ebola research update | 2019 funding deadline reminder
A new approach for understanding Ebola virus pathogenesis
MCMi regulatory science update
In late 2018, FDA awarded a contract to the Broad Institute to conduct the largest Ebola virus and host gene expression study to date. Researchers will use the latest sequencing technologies to assess how Ebola virus evolves and spreads within the body.
This work will help fill significant gaps in the scientific community’s understanding of how Ebola virus disease progresses at the molecular level, which will help identify biological pathways and mechanisms that could be useful biomarkers to assess the efficacy of Ebola medical countermeasures, or advance development of potential therapeutics.
Submit BAA white papers for FY19 by March 29, 2019
Extramural MCM regulatory science is primarily funded through a Broad Agency Announcement(BAA) for research and development to support regulatory science and innovation, under area 7: Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security.
The current BAA announcement will remain open until further notice, but proposers are encouraged to submit white papers by March 29, 2019 for current fiscal year (FY19) awards.
Electronic data standards for Animal Rule studies
Notice of upcoming comment periods and webinar
FDA has been working with the Critical Path Institute and the Clinical Data Interchange Standards Consortium (CDISC) to develop electronic data standards for the natural history and efficacy studies conducted in animals that support Animal Rule applications.
CDISC SENDIG-AR comment period
The draft Standard for Exchange Nonclinical Data (SEND) Implementation Guide for Animal Rule studies (SENDIG-AR) will be available for public review and comment on the CDISC website by February 25, 2019, with the comment period closing on April 12, 2019.
CDISC SENDIG-AR public webinar
A free webinar providing an overview of the SENDIG-AR is scheduled for March 5, 2019, 11:00 a.m. – 12:30 p.m. (ET). Register by March 5, 2019.
Controlled terminology comment period
Critical to the development of data standards is the development of appropriate controlled terminology. A major portion of the controlled terminology associated with the new SENDIG-AR has already completed its public comment period. It is anticipated that the remaining portion of the controlled terminology will be posted for public review and comment from March 22 – April 19, 2019, at CT-P38-Link. (The preceding link will be activated on March 22, 2019, and will not work until that date.)
New!February 28 - March 1, 2019: Disaster Research Response (DR2) Tucson Workshop(Tucson, AZ), hosted by partners including the National Institute of Environmental Health Sciences (NIH), and the University of Arizona College of Medicine - Tucson. FDA representatives plan to attend. Registration will close February 15, 2019, or when capacity is reached.
New! March 14, 2019: Webinar - The Least Burdensome Provisions: Concept and Principles Final Guidance, 1:00 - 2:30 p.m. ET. This final guidance describes the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to the regulation of medical devices.
New! March 26-29, 2019: Preparedness Summit(St. Louis, MO) - Hosted by NACCHO; FDA is a sponsor. This year’s theme is “Preparedness Summit 2019: The Evolving Threat Environment." (fee)
Information for industry
FDA's Center for Devices Radiological Health (CDRH) Experiential Learning Program (ELP) is seeking sites to participate in 2019 training site visits. The 2019 Spring ELP submission period is open through March 4, 2019 at 12:00 p.m. ET.
Draft guidance - S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines (PDF, 1.4 MB) This guidance, which was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), recommends international standards for the nonclinical safety studies recommended to support the development of pediatric medicines. Submit comments to FDA by April 2, 2019. (January 23, 2019)
The National Association of County and City Health Officials (NACCHO) and the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) are accepting applications for the fourth annual National Health Security Award. This award recognizes local health departments that have demonstrated significant accomplishments in implementing health security-related initiatives within their jurisdictions. Apply by April 26, 2019.
From HHS - ASPR has released an updated quadrennial strategy to safeguard the nation’s health in times of crisis. The 2019-2022 National Health Security Strategy (NHSS) provides a vision to strengthen the nation’s ability to prevent, detect, assess, prepare for, mitigate, respond to, and recover from disasters and emergencies. It includes strategies to improve readiness and adapt operational capabilities to address evolving threats such as the use of chemical, biological, radiological, and nuclear (CBRN) weapons; cyber warfare; emerging infectious diseases that could lead to a pandemic; and catastrophic natural disasters and human-caused incidents. Also see: National Health Security Strategy Overview (January 15, 2019)
ver historia personal en: www.cerasale.com.ar [dado de baja por la Cancillería Argentina por temas políticos, propio de la censura que rige en nuestro medio]//
weblog.maimonides.edu/farmacia/archives/UM_Informe_Autoevaluacion_FyB.pdf - //
weblog.maimonides.edu/farmacia/archives/0216_Admin_FarmEcon.pdf - //
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