Areas of activity
Risk management
The risk management plan has to be submitted as part of the application for marketing authorisation. It describes the measures that will be implemented to minimise potential or already known risks once the product has been placed on the market. However, the risk management plan is a work in progress which is continually updated and accompanies a product through its entire lifecylce. The risk management plan is updated whenever new safety signals are detected by the pharmacovigilance system or in cooperation with the marketing authorisation holder.
Signal detection
Continuous monitoring of national and international spontaneously reported adverse reactions and assessment and evaluation of PSURs enables quick and reliable detection of safety signals. We are able to fulfil this obligation through effective data callection and mutual access to pharmacovigilance data within the network of national and international instititutions (EMA, WHO). Safety risks can be directly addresseed by adapting the summary of product characteristics or updating the risk management plan. Here, effective cooperation at the European level is of particular importance because of any measure related to improving drug safety will be effective only if all member states work together.
Risk communication
Providing prescribers and patients with adequate and targeted information about drug safety risks will increase the efficiency of safety measures and accelerate their translation into reality. Besides summaries of product characteristics and patient information leaflets, "Dear Health Care Professional Letters" or modern media such as the internet can play a valuable role in disseminating important safety information.
Created: 06.04.2009