Pharmacovigilance

Knowledge about the safety of medicinal products is not complete at the time of their initial approval. This is mainly due to the fact that the clinical testing of a medicinal product is carried out on a relatively small number of patients, who have also been specially selected for the clinical trial under various aspects. Rare or very rare adverse effects, interactions or other risks associated with the use of medicinal products can therefore usually not be fully identified in clinical trials.

Pharmaceutical legislation in Europe therefore stipulates that once a medicinal product has been approved, the experience gained from its use must be continuously and systematically collected and analyzed. Furthermore, measures to minimize risks should be taken and their effectiveness monitored. This risk identification and minimization is the task of pharmacovigilance.

Focus on pharmacovigilance

The topic of drug safety/pharmacovigilance has become increasingly important in recent years and encompasses all important issues relating to the risk-benefit ratio of medicinal products. To this end, a whole series of regulatory requirements have been drawn up for pharmaceutical companies that stipulate far-reaching obligations, such as the establishment of a pharmacovigilance system within which key personnel and functions are defined. All activities, from the recording and reporting of suspected adverse reactions to the authorities, the evaluation of medical literature and regular statistical analyses to the creation of risk management plans that summarize risks and, if necessary, minimization measures for each medicinal product, are defined in this pharmacovigilance system. And this is checked by the responsible authorities for appropriateness as part of inspections.

Various procedures have also been defined for the official analysis and European coordination of risk minimization measures, the results of which must be implemented by the pharmaceutical companies on a regular basis.

Contact for member companies and authorities

Pharma Deutschland's activities in the field of pharmacovigilance include analyzing and commenting on new legal regulations at European and national level as well as preparing statements on various other topics for its member companies. Pharma Deutschland is in continuous dialog with the authorities and is a competent point of contact for member companies to clarify specific issues. Where necessary, Pharma Deutschland also acts as a mediator or helps to clarify fundamental issues with the authorities.

Pharma Deutschland's Pharmacovigilance Weekly Report regularly informs interested member companies about the latest news in the field of pharmacovigilance and supports the obligation of companies to regularly screen relevant websites with a documentation section.

Projects and services of Wissenschafts- und Wirtschaftdienst (WiDi)

Pharma Deutschland offers its members various projects and services in the area of drug safety, in which synergy effects are used to fulfill the extensive legal regulations. You can find these on our German Page „WiDi-Services“.