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The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is the central government administrative body responsible for the marketing of medicinal products, supervision over the safety of its use and oversight of clinical trials including running the Central Register of Clinical Trials.
An essential step in the process of registering the new medicinal product is to assess its value conducted by specialists in many fields.
It is also necessary exchange of research results, information and opinions which is coordinated by the competent authorities coordinate drug control in the case of registration of the drug in more than one State.
The evaluation process does not end with the registration of the drug. There is essential a continuous process of comparing the results of studies carried out prior to registration and confronting them with that obtained after the registration of the drug.
After the introduction of a medicinal product the safety profile of the drug id recognized within a couple of following years. Typically during the first few years there are detected a rare adverse drug effects which cannot be observed during clinical studies.
Collecting and analyzing signals of adverse reactions reported by healthcare professionals, those responsible and the patients themselves is one of the key tasks carried out by the Office for Registration of Medicinal Products. The analyzed signals are then reported to the relevant EU bodies.
Tasks related to aggregation, analysis, evaluation of safety signals medicinal products are supported by the Management System of Signals designed and implemented by Pentacomp.
It improves the efficiency of the Office for the detection of adverse events that have an impact on the health and lives of people. The system allows the collection of data involved in the assessment signals and provides extensive search capabilities, filtering and comparison.
An extensive analytical part allows the analyzing of data related to the activities of undesirable substances and monitored medicinal products.
It enables automatic determination of potentially important signals, its verification to determine validity and assessment, which significantly improves the performance.
This allows the recommendation for further action and generate results reports ready to forward to appropriate EU institutions.
The system complies with applicable regulations of Polish and European on activities related to pharmacovigilance legislation.