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Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency - Going Beyond the Last Mile: Proceedings of a Workshop (Paperback)
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Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency - Going Beyond the Last Mile: Proceedings of a Workshop (Paperback)
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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 6?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. Table of
Contents Front Matter 1 Introduction and Overview 2 Setting the
Stage: Defining Terminologies and Sharing Stakeholder Perspectives
3 Data Needs, Data Sources, and Collection Methodologies for
Stakeholder Decision Making 4 Considerations for Conducting Rapid
Clinical Research on MCMs During a PHE 5 Inspiring Collective
Action: Perspectives from Federal Stakeholders and Reflections from
Individual Workshop Participants Appendix A: References Appendix B:
Workshop Agenda Appendix C: Biographical Sketches of Workshop
Speakers and Moderators
General
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