Global Health Risk Framework Research and Development of Medical Products: Workshop Summary (2016) / Chapter Skim
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Appendix B: Workshop Statement of Task
Appendix B: Workshop Statement of Task
Pages 89-90
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The overarching objectives for the workshop include • Gathering diverse perspectives of informed stakeholders to foster constructive discussion and facilitate the formation of collaborative solutions; • Characterizing needs and gaps in current approaches to addressing global infectious disease outbreaks and other public health threats, and describing barriers to addressing those needs; • Highlighting opportunities and potential approaches to improve the global system for addressing emerging threats; • Documenting key successes and lessons learned from past global infectious disease outbreaks and other public health emergencies and how they may inform preparation and response to future out breaks and emergencies; and 89
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From page 90... ...
The scope of medical products under consideration at the workshop will include therapeutics, vaccines, diagnostics and other medical devices, and personal protective equipment. Key areas for consideration may include • Product development: describe current product development plat forms; explore science and research needs, including needs for development of appropriate and effective regulatory science and evaluation tools; • Clinical development: discuss clinical trials approaches, including clinical trial methods and ethics considerations around enrollment and access to developing products in an emergency; • Optimization for development: explore incentives and infrastruc ture for product development, and conditions and needs for effec tive public–private partnerships and global/intergovernmental partnerships; • Regulatory review standards and systems: address regulatory con siderations, including approaches to global regulatory harmoniza tion and regulatory systems capacity; • Manufacturing: describe issues pertaining to supply chain manage ment and product quality and integrity, and deployment of medical products; • Legal issues: highlight key legal considerations including developer/ manufacturer liability, distribution/sharing of biological samples, other patent/data exclusivity considerations, and sharing of clinical and clinical trial data; and • Indicators: explore indicators to facilitate and measure success and advances in the face of new and emerging threats.
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