Pharmacovigilance is the science and activities related to the detection, evaluation, knowledge and prevention of adverse reactions and other possible problems related to medications.

It is an instrumental tool for monitoring drugs in their post-marketing phase.
Due to their important role in the population health, pharmacovigilance activities are strongly governed by the different National Health Authorities. The spontaneous notification of adverse effects is the basic cornerstone on which this activity is based and reaches out to all health professionals.

An adverse effect is any harmful, unexpected and unintended response of a drug which occurs at the doses typically prescribed and applied in a person for prophylaxis, diagnosis or treatment of a disease or to modify a biological function.

Those responsible for reporting an adverse effect to a drug are both health professionals and the people affected.

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