Jeesa George Pharmacovigilance during the pre-approval phases-comparison of ICH E2E, CIOMS VI, FDA, EMEA/CHMP & CDSCO risk mangement guidelines - 1 - Mysore JSSCP 2014 - 83p. Savitha R S Subjects--Topical Terms: Clinical Pharmacy Dewey Class. No.: 615. 5 JEE