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Research article

First published 2016-5

Implementing Benefit-Risk Assessment for the Periodic Benefit-Risk Evaluation Report

Margaret R. Warner, Anne M. Wolka, Rebecca A. Noel

Therapeutic Innovation & Regulatory Science

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Research article

First published 1996-11

International harmonisation – the need for transparency

Catherine Hodgkin

International Journal of Risk & Safety in Medicine

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Other

First published 2015-3

General Principles for the Education and Training of GCP Inspectors

Yoshiaki Uyama, Eriko Yamazaki, Katherine Clark [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2001-8

Electronic submission of regulatory information in support of marketing applications for medicinal products. The eCTD: Work in progress

Stan van Belkum

Pharmaceuticals Policy and Law

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Research article

First published 2014-5

ICH: Strengths,Weaknesses,and Future Tasks

Sebastian Specht, Ingrid Klingmann

Therapeutic Innovation & Regulatory Science

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Research article

First published 2002-06

Progress,Innovation and Regulatory Science in Drug Development

John Abraham, Tim Reed

Social Studies of Science

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Other

First published 2000-7

Carcinogenicity Testing of Pharmaceuticals in the European Union: A Workshop Report

Per Spindler, Jan-Willem van der Laan, Peter Ceuppens [...]

Therapeutic Innovation & Regulatory Science

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Meeting report

First published 2005-4

6th Middle East Regulatory Conference (MERC): Key Proceedings

Brian Hewitt, Afschin Khodaverdi-Afaghi, Elaine Whiting [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2013-9

The ICH,the GHTF,and the Future of Harmonization Initiatives

Toshiyoshi Tominaga

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-9

Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework

Ann Meeker-O’Connell, Maria Magdalena Borda, Janis A. Little [...]

Therapeutic Innovation & Regulatory Science

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