How Pharmacovigilance Helps in entire life cycle of Drug Development Vigilarebp.com

1. HOW
PHARMACOVIGILANCE
HELPS IN ENTIRE LIFE
CYCLE OF DRUG
DEVELOPMENT
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2. COLLECTION
Collection in Pharmacovigilance refers to
the process of collecting Individual Case
Safety Reports (ICSRs) which is the first
stage of the Pharmacovigilance process¹.
The safety information comes from
different sources such as solicited &
unsolicited reporting
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3. ANALYSING
Pharmacovigilance analytics can be
defined as the use of advanced analytic
techniques with the purpose of
examining large and varied data sets
containing safety information, to
uncover hidden patterns, unknown
correlations, trends, patient preferences
and usefull information.
2.
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4. MONITORING
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Monitoring in Pharmacovigilance
involves assessing the quality of drugs,
detecting and preventing any adverse
effects of drugs. It involves evaluating
information provided by health care
providers, pharmaceutical companies,
and patients in order to understand the
risks and benefits involved with a
particular drug.
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5. ADVERSE
DRUG REPORTS
ADRs are side effects occurring with a
drug where a positive (direct) causal
relationship between the event and the
drug is thought, or has been proven, to
exist
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6. DETECTION
This step involves detecting any potential
adverse drug reactions. This is done by
monitoring clinical trials, post-market
surveillance, and other data sources.
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7. This step involves assessing the
potential risks and benefits of the drug.
This includes examining the data from
the detection step as well as consulting.
EVALUATION
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8. WE ARE IN ?
Pharmacovigilance is required through
the entire life cycle of a drug – starting
at the preclinical development stage
and going right through to continued
monitoring of drugs once they hit the
market
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