National Academies Press: OpenBook
« Previous: 7 Collaborative Models and New Paradigms for Supporting Regulatory Science Research and Practice
Suggested Citation:"References." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
×

References

EMA (European Medicines Agency). 2010. The European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health, Draft for Public Consultation. London: EMA.

FDA (Food and Drug Administration). 2010. Advancing Regulatory Science for Public Health. http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm228131.htm (accessed November 28, 2011).

FDA. 2011. Advancing Regulatory Science at FDA: A Strategic Plan. http://www.fda.gov/regulatoryscience (accessed November 28, 2011).

FDA Science Board. 2007. FDA Science and Mission at Risk. Rockville, MD: Report of the Subcommittee on Science and Technology.

Hirsch, G. 2011. NEWDIGS: New Drug Development ParadIGmS: Applying MIT systems expertise to transform healthcare innovation. Presentation at IOM workshop on Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development, September 21, Washington, DC.

IOM (Institute of Medicine). 2011. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press.

Mollet, A. 2011. Education and Training of a Regulatory Science Workforce—European Initiatives. Presentation at IOM workshop on Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development, September 20, Washington, DC.

Seyfert-Margolis, V. 2011. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: An Institute of Medicine Workshop. Speaker presentation at IOM workshop on Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development, September 20, Washington, DC.

Ukwu, H. 2011. Regulatory Science in Therapeutics Development. Presentation at IOM workshop on Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development, September 20, Washington, DC.

Suggested Citation:"References." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
×

This page intentionally left blank.

Suggested Citation:"References." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
×
Page65
Suggested Citation:"References." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
×
Page66
Next: Appendix A: Workshop Agenda »
Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary Get This Book
×
Buy Paperback | $31.00 Buy Ebook | $24.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

  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!