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eCTD submissions

Showing 3 posts of 3 posts found.

Talking R&D: eCTD challenges

October 6, 2010
Manufacturing and Production, Research and Development Talking R&D, eCTD, eCTD submissions

The eCTD was of course developed by the ICH (International Conference on Harmonisation) Expert Working Group to make it easier, …

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Talking R&D: Evolving technical standards

October 5, 2010
Manufacturing and Production, Research and Development Talking R&D, eCTD, eCTD submissions

The European Union (EU) Module 1 specification works in parallel with the ICH eCTD Specification. It was first introduced in …

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Talking R&D: US regulatory guidelines

October 4, 2010
Manufacturing and Production, Research and Development Talking R&D, eCTD submissions

Recent speculation surrounding current diabetes drugs and their long term effect on cardiovascular health has heads spinning in the pharmaceutical …

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