1.

Record Nr.

UNINA9910464246403321

Titolo

International regulatory harmonization amid globalization of drug development : workshop summary / / Victoria Weisfeld and Tracy A. Lustig, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy

Pubbl/distr/stampa

Washington, District of Columbia : , : National Academies Press, , [2013]

©2013

ISBN

0-309-28480-5

Descrizione fisica

1 online resource (128 p.)

Disciplina

615.19

Soggetti

Drug development

Electronic books.

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references.

Nota di contenuto

""Front Matter""; ""Reviewers""; ""Contents""; ""Boxes""; ""Acronyms""; ""1 Introduction""; ""2 Principles and Definitional Considerations""; ""3 Overview of the Current Global Regulatory Landscape""; ""4 Areas of Need for Harmonized Standards and Barriers to Progress in Addressing the Gaps""; ""5 Characteristics of Harmonized Regulations and Regulatory Structures""; ""6 Finding Solutions: Options and Systemic Approaches""; ""7 Tactics and Strategies for a Way Forward""; ""References""; ""Appendix A: Workshop Agenda""; ""Appendix B: Participant Biographies""