Pharmacovigilance and Pharmacoepidemiology Dr Ravi Humbarwadi

ISBN: 9781500738112

Published: August 5th 2014

Paperback

208 pages


Description

Pharmacovigilance and Pharmacoepidemiology  by  Dr Ravi Humbarwadi

Pharmacovigilance and Pharmacoepidemiology by Dr Ravi Humbarwadi
August 5th 2014 | Paperback | PDF, EPUB, FB2, DjVu, audiobook, mp3, ZIP | 208 pages | ISBN: 9781500738112 | 4.51 Mb

Pharmacovigilance and Pharmacoepidemiology. MedDRA Coding, ICSR, Types of reports, Causality, SUSAR, EMEA, GVP, Eudravigilance, FDA, MedWATCH, Signal Detection, List of IME, and Narrative Writing. NIS (Non interventional study), PASS (PostMorePharmacovigilance and Pharmacoepidemiology.

MedDRA Coding, ICSR, Types of reports, Causality, SUSAR, EMEA, GVP, Eudravigilance, FDA, MedWATCH, Signal Detection, List of IME, and Narrative Writing. NIS (Non interventional study), PASS (Post authorisation safety study). Role of epidemiology in RMP (Risk Management Plan), CER (Competitive Efectiveness research), Post Marketing risk profile and Post marketing Signals.

Cohort, Case control and study designs. EuPAS, Good Pharmacoepidemiology Practice (GPP), STROBE, EnCePP, Protocol and Guidelines.



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