Subject Details
Dept     : B.Pharm
Sem      : 8
Regul    : 2020
Faculty : staff22
phone  : NIL
E-mail  : staff22@gmail.com
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Syllabus

UNIT
1
Introduction to Pharmacovigilance

GENETICS RELATED ADR ACTIVE SURVEILLANCE EFFECTIVE COMMUNICATION IN PHARAMACOVIGILANCE INTERNATIONAL NON PROPRIETARY NAMES FOR DRUG (INN) URINANLYSIS

UNIT
2
Drug and disease classification

: EDUCATION AND TRAINING PROGRAM HEMATOLOGY CLINICAL PHARMACY CONCEPT OVER THE COUNTER BLOOD CHEMISTRY

UNIT
3
Vaccine safety surveillance

VACCINE SAFETY SURVEILLANCE PHARMACOVIGILANCE METHODS SENTINEL SITES DRUG SAFETY CRISIS MANAGEMENT COMMUNICATION IN PHARMACOVIGILANCE

UNIT
4
Safety data generation

Organization and objectives of ICH Expedited reporting Individual case safety reports Periodic safety update reports Post approval expedited reporting

UNIT
5
Pharmacogenomics of adverse drug reactions

Paediatrics Pregnancy and lactation Geriatrics CIOMS Working Groups D&C Act and Schedule Y

Reference Book:

1.An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers. 2. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones& Bartlett Publishers. 3. Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel, Sean Hennessy,Wiley Publishers.

Text Book:

1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers. 2. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and Bartlett Publishers. 3. Mann's Pharmacovigilance:Elizabeth B. Andrews, Nicholas, Wiley Publishers.

 

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