Overview - a risk management process

As indicated in Chapter 1, pharmacovigilance is essentially a risk management process for medicines. The process starts with identification of a possible hazard, this is then evaluated and investigated and, if necessary, some action is then taken with a view to minimising risk. Implementation requires tools for communicating with users and the final step should be that an assessment of effectiveness is made. The process is iterative because new evidence may emerge or the measures taken may mm out to be insufficient. Rarely can a dmg safety issue be considered completely and permanently resolved. 

As already indicated, the start of the process is usually a signal, i.e. something that needs to be looked at further and which may or may not mm out to be a tme hazard. Before that can happen, there is a need to identify the signal. 

---