Pharmacovigilance within Technic Solutions

Abstract

Inception of harmonised regulatory requirements revealed an important step toward high responsibility for human health safety. The process of regulatory harmonisation goes along with constant simultaneous developing of safe solutions for routine activities. Even though, there is still an empirical collection of various experiences, without sharing of best practices would be the current progress not possible. Similar development undergoes drug safety comprising strategic and operative activities to support pharmaceutical companies to fulfil the responsibility for own products, for public health and for being compliant with the current regulations. Nowadays, drug safety gains more and more significance within “traditional“ activities of pharmaceutical companies: safe data collection, safe processing of the data, safe evaluation and assessment of reports, safe submissions to authorities, safe overview of time frames for periodic reports, safe signal monitoring, safe management of risks of medicinal products. Summarizing, we can speak from safe pharmacovigilance. But what does mean “safe”?