The Working Group was established by the 21st Century Cures Act to improve federal coordination of efforts related to tick-borne diseases. Members will review all HHS efforts related to tick-borne diseases to provide expertise and help ensure interagency coordination and minimize overlap, examine research priorities and identify unmet needs.
The Sentinel Initiative is a national electronic system that monitors the safety of drugs, vaccines, biologics and medical devices on the market. Robert Ball, MD, MPH, deputy director of the FDA Center for Drug Evaluation and Research (CDER) Office of Surveillance and Epidemiology, discusses Sentinel’s progress and future in this CDER Conversation.
FDA will hold the Tenth Annual Sentinel Initiative Public Workshop on February 7-8, 2018 in Bethesda and Silver Spring, MD, and via webcast. The stakeholder community will discuss a variety of topics on active medical product surveillance. To attend in-person or via webcast, register here for Day 1 and/or here for Day 2 by February 6, 2018. To attend both days, please register separately for each.
November 30 - December 1, 2017: Blood Products Advisory Committee Meeting (Silver Spring, MD and webcast) - committee members will meet in open session to discuss topics including strategies to reduce the risk of transfusion-transmitted Zika virus
The NIAID/NIH Centers for Medical Countermeasures against Radiation Consortium (CMCRC) is accepting applications for pilot projects focused on practical approaches for radiation biodosimetry or the development of agents for the mitigation of acute or late radiation injury. Applications are due March 15, 2018.
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) requests proposals for projects that address technology and/or workforce development issues in biomanufacturing. Only NIIMBL members may participate on proposal project teams. Organizations must provide a signed Membership Agreement by January 12, 2018 to submit a proposal or be included on a project team. Also see the full RFP (PDF, 448 KB)
FDA's Center for Biologics Evaluation and Research (CBER) is recruiting for several scientist positions: senior staff fellow/visiting scientists for influenza vaccines and vector-borne diseases, and a staff fellow(interdisciplinary scientist). Apply by January 15, 2018.
FDA Voice - FDA, International Regulators Look at Common Challenges, Innovation - Regulatory experts from around the world (International Coalition of Medicines Regulatory Authorities [ICMRA]), including FDA, gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to combat substandard or falsified medical products. (November 28, 2017)
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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