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The Public Health Emergency Medical Countermeasures Enterprise


The Public Health Emergency Medical Countermeasures Enterprise
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The Public Health Emergency Medical Countermeasures Enterprise


The Public Health Emergency Medical Countermeasures Enterprise
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-07-01

The Public Health Emergency Medical Countermeasures Enterprise written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-07-01 with Medical categories.


During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting national security and the public's well-being. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)-a partnership among federal, state, and local governments; industry; and academia-is at the forefront of the effort to develop and manufacture these countermeasures. However, despite the PHEMCE's many successes, there are still serious challenges to overcome. Government-funded medical research is not always focused on countermeasures for the most serious potential threats, and it is difficult to engage pharmaceutical and biotechnology companies to develop and manufacture medical countermeasures that have a limited commercial market. At the request of the Secretary of the U.S. Department of Health and Human Services and the Assistant Secretary for Preparedness and Response, the IOM held a workshop February 22-24, 2010, to address challenges facing the PHEMCE. Workshop participants discussed federal policies and procedures affecting the research, development, and approval of medical countermeasures and explored opportunities to improve the process and protect Americans' safety and health.



Ensuring An Effective Public Health Emergency Medical Countermeasures Enterprise


Ensuring An Effective Public Health Emergency Medical Countermeasures Enterprise
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher:
Release Date : 2022-08-03

Ensuring An Effective Public Health Emergency Medical Countermeasures Enterprise written by National Academies of Sciences, Engineering, and Medicine and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-08-03 with Medical categories.


The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensuring end-to-end MCM preparedness and response. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise provides recommendations from an expert committee for a re-envisioned PHEMCE. Four priority areas of improvement emerged from committee deliberations: (1) articulating PHEMCE's mission and role and explicating the principles guiding PHEMCE's operating principles and processes, (2) revising PHEMCE operations and processes, (3) collaborating more effectively with external public and private partners, and (4) navigating legal and policy issues.



Hhs Public Health Emergency Medical Countermeasures Enterprise Strategy And Implementation Plan For Chemical Biological Radiological And Nuclear Threats


Hhs Public Health Emergency Medical Countermeasures Enterprise Strategy And Implementation Plan For Chemical Biological Radiological And Nuclear Threats
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Author : HHS Public Health Emergency Medical Countermeasures Enterprise (U.S.)
language : en
Publisher:
Release Date : 2007

Hhs Public Health Emergency Medical Countermeasures Enterprise Strategy And Implementation Plan For Chemical Biological Radiological And Nuclear Threats written by HHS Public Health Emergency Medical Countermeasures Enterprise (U.S.) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Disaster medicine categories.




Hhs Public Health Emergency Medical Countermeasures Enterprise Strategy And Implementation Plan For Chemical Biological Radiological And Nuclear Threats


Hhs Public Health Emergency Medical Countermeasures Enterprise Strategy And Implementation Plan For Chemical Biological Radiological And Nuclear Threats
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Author : HHS Public Health Emergency Medical Countermeasures Enterprise (U.S.)
language : en
Publisher:
Release Date : 2007

Hhs Public Health Emergency Medical Countermeasures Enterprise Strategy And Implementation Plan For Chemical Biological Radiological And Nuclear Threats written by HHS Public Health Emergency Medical Countermeasures Enterprise (U.S.) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Disaster medicine categories.




The Public Health Emergency Medical Countermeasures Enterprise Review


The Public Health Emergency Medical Countermeasures Enterprise Review
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Author : United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
language : en
Publisher:
Release Date : 2010

The Public Health Emergency Medical Countermeasures Enterprise Review written by United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with categories.


The MCM (medical countermeasure) enterprise exists to develop, manufacture, procure, stockpile, and eventually distribute products deemed critical to protecting or treating our population against a variety of naturally occurring or intentionally delivered CBRN threats. However, this MCM enterprise does not exist in a vacuum. It is part of a complex, multi-component system of capabilities necessary to protect our country from a wide range of health threats. This document was prepared in response to the Secretary's request for a review of the MCM development enterprise. HHS recognizes that there are multiple components and organizations essential to the timely development, deployment, and use of MCMs, including critical investment in the Nation's public health system. Indeed, absent the means to detect a health threat or distribute and administer an MCM, investments in the development and manufacturing of MCMs are of limited value. While recognizing these important dependencies, this review is limited to that part of the MCM enterprise that focuses specifically on the processes, policies, and infrastructure required to take a product concept derived from a national requirement through research, early and advanced development, manufacturing, regulatory approval, procurement, and sustained stockpiling. A larger framing of the public health infrastructure needs for national health security is described in the NHSS (National Health Security Strategy).



Public Health Emergency Medical Countermeasures Enterprise Strategy And Implementation Plan


Public Health Emergency Medical Countermeasures Enterprise Strategy And Implementation Plan
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Author : Niel A. Harris
language : en
Publisher: Nova Science Publishers
Release Date : 2013

Public Health Emergency Medical Countermeasures Enterprise Strategy And Implementation Plan written by Niel A. Harris and has been published by Nova Science Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Emergency medical services categories.


The United States continues to face a range of serious threats to its national health security from the deliberate use or accidental release of chemical, biological, radiological, and nuclear (CBRN) agents, as well as from naturally occurring and emerging infectious diseases, including pandemic influenza. This book looks at how the United States has planned and implemented for these threats.



Public Health Emergency Medical Countermeasures Enterprise Strategy And Implementation Plan


Public Health Emergency Medical Countermeasures Enterprise Strategy And Implementation Plan
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Author : Niel A. Harris
language : en
Publisher:
Release Date : 2013

Public Health Emergency Medical Countermeasures Enterprise Strategy And Implementation Plan written by Niel A. Harris and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with HEALTH & FITNESS categories.




2012 Hhs Public Health Emergency Medical Countermeasures Enterprise Phemce Strategy


2012 Hhs Public Health Emergency Medical Countermeasures Enterprise Phemce Strategy
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Author :
language : en
Publisher:
Release Date : 2012

2012 Hhs Public Health Emergency Medical Countermeasures Enterprise Phemce Strategy written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012 with Biological warfare categories.


The U.S. Government has a responsibility to protect the health and safety of its citizens. The American people continue to face a host of national health security threats from chemical, biological, radiological, and nuclear (CBRN) agents (e.g., weapons that could be used to kill or injure a large number of people) and emerging infectious diseases (EID) (e.g., 1918-19 influenza pandemic outbreak). Under the leadership of the Department of Health and Human Services (HHS) the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the coordinating body for the federal agencies in charge of protecting the civilian population from potential adverse health impacts through the use of medical countermeasures, which are medicines, devices, or other medical interventions that can lessen the harmful effects of these threats.



2012 Hhs Public Health Emergency Medical Countermeasures Enterprise Phemce Implementation Plan


2012 Hhs Public Health Emergency Medical Countermeasures Enterprise Phemce Implementation Plan
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Author :
language : en
Publisher:
Release Date : 2012

2012 Hhs Public Health Emergency Medical Countermeasures Enterprise Phemce Implementation Plan written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012 with Biological warfare categories.


This document describes the priorities that HHS, in collaboration with its interagency partners, will implement over the next five years to advance the strategic goals and underlying objectives established in the 2012 PHEMCE Strategy. Under the leadership of the Department of Health and Human Services (HHS) the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the coordinating body for the federal agencies in charge of protecting the civilian population from potential adverse health impacts through the use of medical countermeasures, which are medicines, devices, or other medical interventions that can lessen the harmful effects of these threats. As stated in the Strategy, the PHEMCE is driven by two core principles: (1) the medical and public health imperative to limit the potential adverse health impacts posed by a variety of threats, and (2) the fiduciary responsibility to maximize the preparedness that can be gained with the significant but finite resources available. The Implementation Plan lays out a prioritization framework that is consistent with these core principles, and seeks to best manage the difficult choices facing the PHEMCE, in light of fiscal constraints, scientific limitations, and other factors. Using this prioritization framework the Implementation Plan identifies priority activities across the various PHEMCE mission areas, including requirement-setting; basic research; discovery and early development; advanced development; regulatory science management; procurement and stockpiling; response planning; distribution and dispensing; and monitoring, evaluation, and assessment programs.



Building A National Capability To Monitor And Assess Medical Countermeasure Use During A Public Health Emergency


Building A National Capability To Monitor And Assess Medical Countermeasure Use During A Public Health Emergency
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2018-01-20

Building A National Capability To Monitor And Assess Medical Countermeasure Use During A Public Health Emergency written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-20 with Medical categories.


During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to affected populations to help mitigate the human health impact of the threat. The optimal MCMs determined for use during an emergency might be U.S. Food and Drug Administration (FDA) approved but used in unapproved ways (e.g., in a new age group or against a new agent); FDA approved using animal models because human efficacy testing is not ethical or feasible; or not yet FDA approved for any indication. As part of the United States' scientific and research preparedness enterprise, there is an imperative to go "beyond the last mile" of MCM dispensing and administration to build and maintain a national capability to monitor and assess the use of MCMs (e.g., safety, compliance, clinical benefit) after they have been dispensed during PHEs. To further the discussion on this need, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 2-day public workshop, Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies. The workshop, sponsored by FDA, was held on June 6â€"7, 2017, in Washington, DC. Workshop participants discussed the roles and efforts of the federal government and of relevant stakeholders with an interest in building and maintaining a national PHE MCM active monitoring and assessment capability. This publication summarizes the presentations and discussions from the workshop.