Dr. Leonardo Ebeling, Dr. Reingart Bordel, Pharmind, 12/2007, S. 1390-1395 Designing Efficient Pharmacovigilance Systems EudraLex Volume 9A requires Marketing Authorisation Holders to invest considerable manpower and financial resources in monitoring the safety of pharmaceutical products. At the same time, the law also permits companies to avail of the services of external service providers for pharmacovigilance (PV). Cooperation with service providers, in turn, places special requirements on the PV system operated by the pharmaceutical company. It is imperative that tasks and interfaces are clearly defined. Here is an overview of the possibilities and limits for outsourcing PV activities in Germany. more >>
