OBJECTIVE
- The launch of an independent discussion platform for the identification and debate of the most important subjects regarding drug safety, for the benefit of the patient.
- Positioning the event as an expert event from the point of view of relevant information for drug safety.
- Debating the implications of national and international regulations in the field (Technical session addressed to professionals).
CONTEXT
- Pharmacovigilance, defined by the World Health Organization as being „the science and activities relating to the detection, assessment, understanding and prevention of adverse effects”, it is one of the areas of interest with the steepest growth in the medical field. This area is essential for monitoring public health and for institutionalizing the safe use of medicine.
- The increase of incidence of chronic and non-chronic conditions is the main determining factor for demand of medicines. For this reason, this global increase is directly proportional with the consumption of pharmaceutical products and in extension with the occurrence of adverse events. As a result, an increase in demand for medicines monitoring and regulation is estimated to occur.
- Considering the fact that safety in medication administration is a significant global problem, there is an obvious justification of the tendency to regulate, standardize and allocation of resources for local and regional implementation, even from the early 2000s.
- Technology, which has improved the connectivity and data exchange, also determines a/an tendency to increase/upward trend.
- The European Union created “Good Pharmacovigilance Practices” (GVP), following the implementation of pharmacovigilance regulation from 2012, which monitors adverse medicines reactions in the member states. Pharmacovigilance providers must follow standard instructions and procedural safety checks in all the stages of medicines’ testing.
- However, pharmacovigilance is not the sole component that targets the safe use of medication. Both responsible patient communication and facilitating patient access to therapies are needed in a modern, regulatory framework tailored to today’s realities.