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HOW
PHARMACOVIGILANCE
HELPS IN ENTIRE LIFE
CYCLE OF DRUG
DEVELOPMENT
Vigilarebp.com 1 / 9
Swipe Left
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
Swipe Left
1.
2 / 9
Vigilarebp.com
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.
Swipe Left
3 / 9
Vigilarebp.com
MONITORING
3.
Swipe Left
4 / 9
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.
Vigilarebp.com
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
4.
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5 / 9
Vigilarebp.com
DETECTION
This step involves detecting any potential
adverse drug reactions. This is done by
monitoring clinical trials, post-market
surveillance, and other data sources.
5.
Swipe Left
6 / 9
Vigilarebp.com
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
6.
Swipe Left
7 / 9
Vigilarebp.com
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
8 / 9
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DON'T FORGET TO
LIKE, REPOST
AND ASK US FOR
MORE.
9 / 9
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Pharmacovigilance Helps in entire life cycle of Drug Development

  • 1. HOW PHARMACOVIGILANCE HELPS IN ENTIRE LIFE CYCLE OF DRUG DEVELOPMENT Vigilarebp.com 1 / 9 Swipe Left
  • 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 Swipe Left 1. 2 / 9 Vigilarebp.com
  • 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. Swipe Left 3 / 9 Vigilarebp.com
  • 4. MONITORING 3. Swipe Left 4 / 9 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. Vigilarebp.com
  • 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 4. Swipe Left 5 / 9 Vigilarebp.com
  • 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. 5. Swipe Left 6 / 9 Vigilarebp.com
  • 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 6. Swipe Left 7 / 9 Vigilarebp.com
  • 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 8 / 9 Vigilarebp.com
  • 9. DON'T FORGET TO LIKE, REPOST AND ASK US FOR MORE. 9 / 9 www.Vigilarebp.com