Advancing the discipline of regulatory science for medical product development : an update on progress and a forward-looking agenda : workshop summary : proceedings of a workshop / Morgan L. Boname, Amanda Wagner Gee, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation [and three others].

Format:

Book

Conference/Event

Author/Creator:

Boname, Morgan L., rapporteur.

Contributor:

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

Boname, Morgan L., rapporteur.

Wagner Gee, Amanda, rapporteur.

Claiborn, Anne B., rapporteur.

Conference Name:

Advancing the Discipline of Regulatory Science for Medical Product Development: an Update on Progress and a Forward-Looking Agenda (Workshop) (2015 : Washington, D.C.)

Language:

English

Subjects (All):

United States. Food and Drug Administration.

United States.

Pharmaceutical policy--United States.

Pharmaceutical policy.

Drug development--Technological innovations--United States.

Drug development.

Medical Subjects:

United States.

Physical Description:

1 online resource (105 pages) : illustrations

Edition:

1st ed.

Place of Publication:

Washington, District of Columbia : The National Academies Press, 2016.

Summary:

"The field of endeavors known as 'regulatory science' has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop"--Publisher's description.

Contents:

Introduction

Characterizing the Implementation science landscape

Regulatory science applications: using case studies to focus on approaches to advance the discipline

Regulatory science infrastructure and workforce

Challenges and opportunities in regulatory science

Appendix A: Bibliography

Appendix B: Workshop agenda

Appendix C: Participant biographies.

Notes:

Includes bibliographical references at the end of each chapters.

Description based on online resource; title from PDF title page (ebrary, viewed July 26, 2016).

ISBN:

9780309438872

030943887X

9780309438858

0309438853