All Clinical trial application (CTA) articles
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Industry newsMHRA cuts approval times for UK clinical trials in half
This industry news update announces the MHRA’s decision to reduce clinical trial approvals from 91 days to 41 days.
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JournalCentral sourcing of authorised comparators and concomitant medications for multiregional clinical trials in accordance with ICH E17: CMC documentation requirements
This article uses the ICH E17 document to explore chemistry, manufacturing and controls requirements for inclusion in a clinical trial application.
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JournalPS1: Resolving specific development hurdles via scientific advice
Regulatory Rapporteur November 2024 | Volume 21 | No.10 Leaders: Sandra Lourenço, Director of Regulatory Affairs, Arriello, Ireland Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety, Austria Speakers: Peggy Sarah, the ...
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