Strengthening a workforce for innovative regulatory science in therapeutics development : workshop summary / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation ; Board on Health Sciences Policy.

Format:

Book

Conference/Event

Author/Creator:

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development, Corporate Author.

Contributor:

Olsen, Steve.

Claiborne, Anne B.

Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation.

Institute of Medicine (U.S.). Board on Health Sciences Policy.

Conference Name:

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development (2011 : Washington, D.C.)

Language:

English

Subjects (All):

Drug development--United States--Congresses.

Drug development.

United States. Food and Drug Administration--Personnel management--Congresses.

United States.

Physical Description:

1 online resource (119 p.)

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academies Press, 2012.

Language Note:

English

Summary:

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-- Source other than Library of Congress.

Contents:

""Front Matter""; ""Reviewers""; ""Contents""; ""Figures and Boxes""; ""Acronyms""; ""1 Introduction""; ""2 The Importance of Innovative Regulatory Science""; ""3 Defining a Discipline of Regulatory Science and Core Competencies for Its Workforce""; ""4 Education and Training of a Regulatory Science Workforce""; ""5 Career Paths Within Academia and Industry""; ""6 International Applications of Regulatory Science""; ""7 Collaborative Models and New Paradigms for Supporting Regulatory Science Research and Practice""; ""References""; ""Appendix A: Workshop Agenda""

""Appendix B: Participant Biographies""

Notes:

"Forum on Drug Discovery, Development, and Translation ; Board on Health Sciences Policy."

Includes bibliographical references.

ISBN:

0-309-22217-6

1-280-38019-5

9786613558107

0-309-22215-X

OCLC:

923288168