Pharmacovigilance is the process of monitoring and reporting adverse drug reactions (ADRs) and other safety concerns associated with the use of pharmaceutical products. Here is an infographic that explains the Pharmacovigilance process in detail. Visit DDReg Pharma to learn more.

1. Causality Assessment
Signal Detection
Adverse Event Reporting
The process starts with collecting information on
adverse events (AEs) or adverse drug reactions
(ADRs) in patients who have taken the drug. This
can be done through spontaneous reporting,
literature searches, or clinical trials.
1
Case Management
Once an adverse event is reported, it is reviewed
by a pharmacovigilance expert, who determines if
it is a genuine ADR. The case is then managed
and tracked to ensure that all necessary
information is collected.
2
A causality assessment is done to determine
whether the reported ADR is related to the drug
in question. This involves analyzing the temporal
relationship, patient characteristics, and other
relevant factors.
Risk Assessment
The next step is to assess the risk associated with
the ADR. This involves determining the severity
and frequency of the ADR and the potential
impact on patient safety.
3
4
Risk Management
Once a safety concern has been identified, a risk
management plan is developed to minimize
patient risk. This may involve updating product
labeling, changing the prescribing information, or
removing the product from the market.
6
Signal detection identifies potential safety
concerns that may not have been reported. This
is done by analyzing data from multiple sources,
such as clinical trials and post-marketing
surveillance.
5
Regulatory Reporting
Finally, all ADRs and safety concerns are reported
to the regulatory authorities, such as the FDA or
EMA. This ensures that the safety profile of the
drug is continuously monitored and updated as
new information becomes available
7
A COMPREHENSIVE GUIDE
TO PHARMACOVIGILANCE
E N S U R I N G S A F E A N D E F F E C T I V E U S E O F D R U G S
www.ddregpharma.com