International Conference periodic safety update report

Clearly, therefore, those involved in drug safety monitoring need to liase closely with both clinical research and medical information scientists. In addition, those responsible for clinical drug safety must undertake periodic safety update reports (PSURs) at predetermined intervals, in accordance with current International Conference on Harmonisation (ICH) guidelines. Such routine analyses can identify new safety signals as soon as they become detectable. 

Clinical Safety Data Management Periodic Safety Update Reports for Marketed Drugs, International Conference on Harmonization [ICH] of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1996. http //www.ifpma.org/pdfifpma/ e2c.pdf. 

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