Pascha Clark-Higgs
Pascha Clark-Higgs is Associate Director of Regulatory Affairs at PPD, a part of Thermo Fisher Scientific.
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.