National Academies Press: OpenBook
« Previous: Appendix A: References
Suggested Citation:"Appendix B: Workshop Statement of Task." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

B

Workshop Statement of Task

GLOBAL HEALTH RISK FRAMEWORK: A WORKSHOP ON RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS

An ad hoc committee will plan and conduct a 3-day public workshop that will provide a forum for relevant stakeholders to describe and provide input on the core needs and strategies to facilitate development of medical products to prevent, diagnose, treat, and protect from emerging threats such as global infectious diseases. The committee will define the specific workshop topics to be addressed, develop the agenda, select and invite speakers, and moderate workshop discussions.

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 outbreaks and emergencies; and
Suggested Citation:"Appendix B: Workshop Statement of Task." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
  • Considering indicators and metrics that may be used to guide and assess the resilience of the global health infrastructure to future outbreaks and emergencies.

Speakers and workshop participants will be invited to describe and examine systems and approaches to discover and develop medical products to address emerging threats. The focus of the workshop will be on global systems and policy needs to foster communication, partnerships, and other strategies to advance medical product development. Workshop discussions will describe and examine the current state of approaches and infrastructure for research and development, barriers to the effective and efficient development of medical products, and potential strategies to address impediments to the research or development processes. 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 platforms; 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 infrastructure for product development, and conditions and needs for effective public–private partnerships and global/intergovernmental partnerships;
  • Regulatory review standards and systems: address regulatory considerations, including approaches to global regulatory harmonization and regulatory systems capacity;
  • Manufacturing: describe issues pertaining to supply chain management 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.

A summary will be prepared by a designated rapporteur based on the information gathered and discussions held during the workshop.

Suggested Citation:"Appendix B: Workshop Statement of Task." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 89
Suggested Citation:"Appendix B: Workshop Statement of Task." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 90
Next: Appendix C: Workshop Agenda »
Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary Get This Book
×
Buy Paperback | $45.00 Buy Ebook | $35.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

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.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!