# \[e-drug\] Training "Pharmacovigilance and Drug Monitoring" November 14-18, 2016

**URL:** <https://talk.edrugplus.org/t/e-drug-training-pharmacovigilance-and-drug-monitoring-november-14-18-2016/42972>\
**Category:** e-drug\
**Created:** [August 12, 2016, 6:44am UTC](https://talk.edrugplus.org/t/e-drug-training-pharmacovigilance-and-drug-monitoring-november-14-18-2016/42972 "2016-08-12T06:44:56Z")\
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**Author:** ![rahul\_sharma](https://avatars.discourse-cdn.com/v4/letter/r/df705f/32.png) [@rahul\_sharma](https://talk.edrugplus.org/u/rahul_sharma)\
**Post date:** [August 12, 2016, 6:44am UTC](https://talk.edrugplus.org/t/e-drug-training-pharmacovigilance-and-drug-monitoring-november-14-18-2016/42972/1 "2016-08-12T06:44:56Z")

</div>

E-DRUG: Training "Pharmacovigilance and Drug Monitoring" November 14-18, 2016  
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IIHMR University, Jaipur, India announces a 5 days training program for  
health professional on Pharmacovigilance and Drug Monitoring starting  
from November 14, 2016

Rationale of the program

There is an increase in the number of medicinal use and also rise in  
adverse drug events and medicines related toxicities. With the utmost  
importance on patient safety and regulatory compliance, healthcare  
professional must effectively monitor and report adverse event to with all  
regulatory standards.

Major Objective

The aim of the program is to strengthen participants with concepts and  
current practices in Pharmacovigilance and to support public health  
programmes by providing reliable, balanced information for the safe and  
effective use of medicines.

Program Contents  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· National Pharmacovigilance Program  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Management and Importance of Pharmacovigilance

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Adverse event (AE) definition & reporting  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Current status & issues of Post marketing studies  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Design of Post marketing studies  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Signal Detection & analysis  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Causality assessment of adverse event  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Setting-up of PV center & Operationalization  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Drug Coding & PV Data Management  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Spontaneous Reporting  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Periodic Safety Update Report  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· ICH- GCP Guidelines & Global PV Regulation  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Role of Stakeholders  
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Issue work-up of aggregate data-consideration of  
preclinical, clinical, epidemiological, safety database, aggregate analysis

The program consist of extensive practicable, training and learning  
activities with major emphasis on understanding different Pharmacovigilance  
issues.

Kindly refer to brochure

[https://drive.google.com/open?id=0By4H6jhT35mtbVZmSC1KRXlmVEk](https://drive.google.com/open?id=0By4H6jhT35mtbVZmSC1KRXlmVEk)

or contact  
program coordinator for more details. The details can also be collected  
from official web site:  
[https://iihmr.edu.in/trainings](https://iihmr.edu.in/trainings)

Nomination  
[https://drive.google.com/open?id=0By4H6jhT35mtdjllb3FDdkRVV2s](https://drive.google.com/open?id=0By4H6jhT35mtdjllb3FDdkRVV2s)  
of the program can be forwarded on before 31 October, 2016 to:

Prof. Rahul Sharma (Programme Coordinator),  
IIHMR University,  
1 P.D. Marg, Sanganer Airport, Jaipur, India - 302 029

Email: rahulsharma@iihmr.edu.in,  
training@iihmr.edu.in,  
rahulsharma1in@gmail.com