Pharmacovigilance during the pre-approval phases-comparison of ICH E2E, CIOMS VI, FDA, EMEA/CHMP & CDSCO risk mangement guidelines

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Language: English Publication details: Mysore JSSCP 2014Edition: 1Description: 83pSubject(s):

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Dissertation note: Savitha R SJSS UniversityClinical Practice and Research

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Holdings
Item type	Current library	Home library	Collection	Call number	Status	Barcode
Dissertation/Thesis	JSS College of Pharmacy, Mysuru	JSS College of Pharmacy, Mysuru	Pharmacy Practice	615. 5 JEE (Browse shelf(Opens below))	Available	D09118

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Previous	615. 5 BAL Discrepancy management in clinical data management	615. 5 DIL Clinical trial application: global regulatory overview	615. 5 GOP Recent development in regulation of clinical trials in Asia and their implications on clinical research industry in India	615. 5 JEE Pharmacovigilance during the pre-approval phases-comparison of ICH E2E, CIOMS VI, FDA, EMEA/CHMP & CDSCO risk mangement guidelines	615. 5 KOT Review of regulatory submission guidelines on clinical study reports	615. 5 SAB Assessment of potential areas of synergy between clinical operational team and clinical data management team	615. 5 SIK Conducting clinical research department process audit: methodology and findings	Next