E2C(R1) definition
E2C(R1) is the tripartite harmonised ICH guideline on the format and content of safety updates, which need to be provided at intervals to regulatory authorities after products have been marketed. E2C(R1) means the addendum to E2C on Periodic Safety Update Reports for marketed drugs (PSURs), and is always used in conjunction with E2C.
Examples of E2C(R1) in a sentence
Annual summary reports may be submitted in the form of a Periodic Safety Update Report (PSUR) as defined by ICH E2C(R1) guideline.