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First published 2002-10

The Impact of the Implementation of the International Conference on Harmonisation Essential Documents on Investigator Sites

Luis Peña Icart, Olga J. Torres Gemeil, Jose Cevallos [...]

Therapeutic Innovation & Regulatory Science

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First published 2001-4

International Conference on Harmonization-Keeping International Drug Development in Harmony?

Craig McCarthy

Therapeutic Innovation & Regulatory Science

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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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First published 2003-4

Taiwan's Experience with the Assessment of the Acceptability of the Extrapolation of Foreign Clinical Data for Registration Purposes

Yeong-Liang Lin, Herng-Der Chern, Mong-Ling Chu

Therapeutic Innovation & Regulatory Science

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First published 2005-4

Clinical Trial Capacity in East Africa: A Pilot Survey

Ebi Kimanani, Timothy Johns

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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First published 2005-10

Modeling and Interpreting QTc Prolongation in Clinical Pharmacology Studies

Scott D. Patterson, Byron Jones, Névine Zariffa

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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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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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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