'Ctd format' diaporamas de présentation

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Regulatory Requirement on Dossier of Medicinal Products WHO Workshop, October 2007

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Regulatory Requirement on Dossier of Medicinal Products WHO Workshop, October 2007

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The situation on GMP- and regulatory compliance for APIs manufactured in China

The situation on GMP- and regulatory compliance for APIs manufactured in China . Yueping Sun Beijing CHNMED Pharmaceutical Consulting Co., Ltd. syp@chnmed.com.cn October 24, 2007. Introduction of CHNMED.

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The Evolution of ICH Shift From Input to Output-- The Influence of the CTD

The Evolution of ICH Shift From Input to Output-- The Influence of the CTD. Justina A. Molzon, MS Pharm, JD Associate Director for International Programs Center for Drug Evaluation and Research US Food and Drug Administration. Topics for Discussion.

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eCTD

eCTD. An overview of the full day presentation by Dr Olaf Schoepke at the SAAPI conference in July 2008. Overview. History Why go electronic? Types of electronic submissions What eCTD consists of Preparing eCTD Eye openers and bombshells Conclusion. eSubmissions history.

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Common Technical Document

Common Technical Document. AstraZeneca strongly supports CTD and seeks to utilise it as soon as is feasible. In deciding upon strategies for implementation, AstraZeneca would ask that the following points be taken into account :.

756 views • 1 slides