The National Academies Press

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1 Introduction
Pages 1-4

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From page 1... ... Moreover, in the private sector, including industry and academia, the advancement of the science of innovation in drug discovery and development has not always been clearly defined, well coordinated, or connected to the needs of the regu latory agency. A number of gaps in the regulatory science discipline and infrastructure have been identified, including workforce and resource constraints not only within FDA but also in the extramural community; cultural differences and systemic barriers to collaboration and exchange among the agency, academia, and industry; and deficiencies in the net 1 The planning committee's role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Read the entire page →
From page 2... ... . As a follow-on to that workshop, and building on pronouncements from and developments to advance regulatory science at FDA in the interim months, the Forum convened a workshop on September 20-21, 2011, entitled "Strengthening a Workforce for Innovative Regulatory Sci ence in Therapeutics Development." This workshop provided a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and infrastructure as articulated in the 2010 workshop on regulatory science. Read the entire page →
From page 3... ... SCOPE OF THE WORKSHOP AND ORGANIZATION OF THE SUMMARY Over the course of the workshop many participants offered their individual definitions of the concept of regulatory science in therapeutics development and elaborated on how regulatory science relates to drug development more generally. Although the scope of the workshop was focused on regulatory science in therapeutics development, a number of workshop discussants offered viewpoints or illustrations that were relevant to regulatory science more generally (e.g., application of regulatory science to regulation of tobacco products; post-approval safety monitoring of therapeutics) Read the entire page →
From page 4... ... • Chapter 6 considers international dimensions and needs for a regu latory science workforce to achieve innovation on a global scale. • Chapter 7 reviews new collaborative models to strengthen and support regulatory science research and practice and provides par ticipant summaries of the workshop discussions and suggestions for moving the field forward. Read the entire page →

From page 1...

... Moreover, in the private sector, including industry and academia, the advancement of the science of innovation in drug discovery and development has not always been clearly defined, well coordinated, or connected to the needs of the regu latory agency. A number of gaps in the regulatory science discipline and infrastructure have been identified, including workforce and resource constraints not only within FDA but also in the extramural community; cultural differences and systemic barriers to collaboration and exchange among the agency, academia, and industry; and deficiencies in the net 1 The planning committee's role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop.

Read the entire page →

From page 2...

... . As a follow-on to that workshop, and building on pronouncements from and developments to advance regulatory science at FDA in the interim months, the Forum convened a workshop on September 20-21, 2011, entitled "Strengthening a Workforce for Innovative Regulatory Sci ence in Therapeutics Development." This workshop provided a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and infrastructure as articulated in the 2010 workshop on regulatory science.

Read the entire page →

From page 3...

... SCOPE OF THE WORKSHOP AND ORGANIZATION OF THE SUMMARY Over the course of the workshop many participants offered their individual definitions of the concept of regulatory science in therapeutics development and elaborated on how regulatory science relates to drug development more generally. Although the scope of the workshop was focused on regulatory science in therapeutics development, a number of workshop discussants offered viewpoints or illustrations that were relevant to regulatory science more generally (e.g., application of regulatory science to regulation of tobacco products; post-approval safety monitoring of therapeutics)

Read the entire page →

From page 4...

... • Chapter 6 considers international dimensions and needs for a regu latory science workforce to achieve innovation on a global scale. • Chapter 7 reviews new collaborative models to strengthen and support regulatory science research and practice and provides par ticipant summaries of the workshop discussions and suggestions for moving the field forward.

Read the entire page →

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1 Introduction Pages 1-4

1 Introduction
Pages 1-4