All pharmaceutical companies need one: a qualified person for pharmacovigilance (QPPV) as defined in EU Directive 2001/83/EC is obliged to run the pharmacovigilance system for pharmaceutical manufacturers. The QPPV has to collect and evaluate reports on drug risks and coordinate any necessary actions, and even more.
Pharmaceutical companies throughout Europe require a QPPV. Regulation (EC) 724/2004 and EU Directive 2001/83/EC, which has been implemented into national law, are the legal basis for this requirement. As a result, the QPPV must be available 24/7, 365 days a year. Diapharm is the perfect partner for pharmaceutical companies that need to cover peaks and vacation times or wish to outsource QPPV responsibilities.
This service helps our clients fulfil European and national pharmacovigilance requirements without having to add additional capacities while guaranteeing QPPV availability as required: