Compliance-Management in der Pharmakovigilanz
europharm
Abstract
Compliance Management in Pharmacovigilance
With the changing regulatory landscape, compliance management became increasingly important over the last couple of years. Compliance management describes the set of measures and processes in place in order to detect and prevent breach of rules such as laws, standards or internal policies. Marketing authorisation holders are required to establish compliance management as part of their pharmacovigilance quality system. At the same time companies have the opportunity to use these procedures aimed to increase patient safety as a tool in order to implement measures and improvements much faster, also allowing them to save litigation and process costs. The prerequisites for the successful implementation of a compliance management system are adequate structures, processes and infrastructure. In this regard multidisciplinary safety boards play a vital role as they foster collaboration and a continuous improvement process. Furthermore, key performance indicators which can be of operative and strategic nature are required for successful controlling and development. The case study presented in this paper demonstrates how compliance management can be implemented in practice.
 | Dr. Matthias Hoffmann studierte Chemie an den Technischen Universitäten Darmstadt und Dresden. Im Anschluss an seine Promotion war er zunächst in der Medizinprodukte-Branche tätig, wo er sich mit den Themen CE-Kennzeichnung, internationale Zulassung sowie Risiko- und Qualitätsmanagement beschäftigte. Nach verschiedenen Stationen im Marketing und Produktmanagement internationaler Unternehmen wechselte er 2012 zu PharmaLex, wo er unter anderem für Dienstleistungen in den Bereichen Pharmakovigilanz, Medical Device Vigilance, Safety Data Exchange Agreements sowie Qualitätsmanagement |
