From Adverse Events to Risk management. Munir Anwar Ph. D Chief Operating Officer Martin Dow limited. Why Pharmacovigilance?. Started with the administration of plants as medication in old ages…. Why Pharmacovigilance?. : Thalidomide disaster. : WHO resolution laying basis of
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Munir Anwar Ph. D
Chief Operating Officer
Martin Dow limited
monitoring of adverse drug reactions
1995 : EMEA
The detection, evaluation, understanding and prevention of adverse drug reactions of marketed drugs (PV).
The risk management of drugs during their whole lifecycle.
Disease : evolution, complications
Population treated : age, concurrent illness,
concomitant usual treatment.
290 and 700nm are at risk, photoinstability.
Antacids : block absorption of many drugs
interval of 2 hours between intake.
Drug – food interaction
Grapefruit juice inhibits intestinal CYP CA4 which
affects drug metabolism
Drug – disease interaction :
Interaction on the target organ:
Addition of effects
Routine pharmacovigilance practices
Should take into consideration :
The International Conference on Harmonization (ICH) definition of an adverse event is "any untoward (undesirable) medical occurrence in a patient ... administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment."
Serious adverse events (SAE's) resulting from the use of thalidomide were not immediately reported from 1957 to 1961.
This occurred prior to the implementation of federal regulations governing the reporting of adverse events associated with pharmaceutical products.
As a result, 10,000 children in 12 countries were born with deformities.
Risk benefit Ratio is always change. SAE reporting will help it to understand better
An adverse event is considered serious if the event results in any of the following:
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