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Our comprehensive pharmacovigilance solutions include:
Qualified person responsible for pharmacovigilance (QPPV)
According to EU Directive 2001/83/EC, as implemented in national law, every marketing authorization holder needs to nominate a qualified person responsible for pharmacovigilance. Key tasks include:
German Graduated Plan Officer (GPO; Stufenplanbeauftragter, §63a AMG)
According to the German Medicinal Products Act (AMG), the Graduated Plan Officer is personally responsible for all aspects of pharmacovigilance. The Graduated Plan Officer was introduced into German law in 1986 and served as a role model when the concept of having a single person responsible for pharmacovigilance was adopted at a European level by introducing the so called QPPV with EU Directive 2001/83/EC. Today, the German Graduated Plan Officer incorporates all responsibilities foreseen for a QPPV according to EU Directive 2001/83/EC. Furthermore, he is personally responsible for evaluating product defects and managing recalls.