Changes of the German Drug Law (AMG) in conjunction with complex requirements for Drug Safety Monitoring have led to the establishment of a formalized Pharmacovigilance system. The role of the Qualifi ed Person for Pharmacovigilance (QPPV) is important to implement and maintain the obligations for Pharmacovigilance of your organization. We offer to take this role on for your organization to save your time and expense.
Your obligations are our commitment!
- evaluation of the existing setting (literature research, reporting, PSURs, alarm plans, etc.),
- implementation of PV systems,
- compilations of Risk Management Plans (RMPs),
- tailor-made solutions for your organisation-training and internal audits, etc.