Essential activities in Pharmacovigilance

There are five broad activities that are essential to pharmacovigilance. These are:

• suspected ADR signal generation and formation of hypotheses,
• analysis of all issues around the signal, particularly confirmation (or refutation) of hypotheses,estimation of the size of the risk and whether susceptible patients exist,
• consideration of possible changed benefit-to risk issues in therapy,
• communication of information to health professionals and patients in a useful way and possible regulatory action;
• consequence evaluation.