Pharmacovigilance Services

Services of an (EU) QPPV and Graduated Plan Officer (Stufenplanbeauftragter)

Our comprehensive pharmacovigilance solutions include:

  • continuously providing the services of an (EU) QPPV and Deputy QPPV with 24 h availability,
  • serving as Graduate Plan Officer (Stufenplanbeauftragter) according to German law,
  • on-site interim management of your pharmacovigilance department
  • providing a complete Pharmacovigilance System
  • performing pharmacovigilance training

 

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:

  • Continuously monitoring the benefits and risks of medicinal products.
  • Evaluating case reports concerning adverse reactions
  • Maintenance of the pharmacovigilance system
  • Serving as a pharmacovigilance contact person with 24 h availability

 

German Graduated Plan Officer (GPO; Stufenplanbeauftragter, ยง63a 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.