DRUG SAFETY PHARMACOVIGILANCE & PHARMACOEPIDEMIOLOGY & DATABASE

DRUG SAFETY PHARMACOVIGILANCE & PHARMACOEPIDEMIOLOGY & DATABASE

Pharmacovigilance: The principles and practice of pharmacovigilance. Case processing guidelines and CIOMS format. With examples of MedDRA coding, regulatory process including EMEA, FDA and GVP 2012. List of IME (useful in day to day operations to help decide serious vs non-serious cases). Pharmacoep...

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Bibliographic Details
Main Author: Humbarwadi, Ravi (Author)
Format: Book
Language:English
Published: India CreateSpace Independent Publishing Platform 2015
Subjects:
Pharmacovigilance
Pharmacoepidemiology
Online Access:Click Here to View Status and Holdings.
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Summary:Pharmacovigilance: The principles and practice of pharmacovigilance. Case processing guidelines and CIOMS format. With examples of MedDRA coding, regulatory process including EMEA, FDA and GVP 2012. List of IME (useful in day to day operations to help decide serious vs non-serious cases). Pharmacoepidemiology : Study Designs - Types of designs and their use in different situations. Comprehensive description of NIS. Protocol, STROBE, ENCePP and Good pharmacoepidemiology Practices.Pharmacovigilance Database : Graphic Description. Field by Filed and Module by Module. Includes Overview of Oracle ARGUS. A MEGA BOOK OF DRUG SAFETY.
Physical Description:199 pages 28 cm
ISBN:9781511686785

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