Part of the Policy 70 submission package. It should describe the methodology of the anonymisation applied in the submitted clinical reports, and how the risk of re-identification has been addressed.
Part of the Policy 70 submission package. It should describe the methodology of the anonymisation applied in the submitted clinical reports, and how the risk of re-identification has been addressed.
Format and content for periodic reporting on drugs under development (ICH-E2F Guideline, Volume 10 of…
View definitionNonviable substance produced by or derived from microorganisms, which, when administered in adequate amount, confer…
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