Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond the three hardest-hit countries and beyond the health sector. Education, child protection, commerce, transportation, and human rights have all suffered. The consequences and lethality of Ebola have increased interest in coordinated global response to infectious threats, many of which could disrupt global health and commerce far more than the recent outbreak.
In order to explore the potential for improving international management and response to outbreaks the National Academy of Medicine agreed to manage an international, independent, evidence-based, authoritative, multistakeholder expert commission. As part of this effort, the Institute of Medicine convened four workshops in summer of 2015 to inform the commission report. The presentations and discussions from the Workshop on Research and Development of Medical Products are summarized in this report.
Table of Contents
|2 Models and Incentives for Engagement||11-24|
|3 Discovery Research||25-38|
|5 Convergence of Regulatory Expectations, Review, and Approval||55-62|
|6 Manufacturing, Stockpiling, and Distribution||63-74|
|7 Critical Considerations for Facilitating Medical Product Research and Development||75-82|
|8 Crosscutting Themes and Closing Remarks||83-86|
|Appendix A: References||87-88|
|Appendix B: Workshop Statement of Task||89-90|
|Appendix C: Workshop Agenda||91-100|
|Appendix D: Workshop Speaker Biographies||101-124|
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