Pharmacovigilance system development
With amendments to Regulations (EC) 726/2004 and 520/2012 as well as Directive 2001/83/EC in recent years, the requirements for monitoring drug safety have become greatly formalised. The qualified person for pharmacovigilance (QPPV) is responsible for establishing and maintaining a company’s pharmacovigilance system.
We act in this capacity for pharmaceutical companies by performing a number of services, including the following:
- Evaluation of existing pharmacovigilance activities (SOPs, literature research, reporting, PSURs, alarm plans, etc.) and measures to minimise risk
- Establishing and summarising pharmacovigilance systems (pharmacovigilance system master file, PSMF) for pharmaceutical companies, including annexes
- Compilation of risk management plans (RMP)
- Conducting internal audits
- Preparation for and assistance with inspections by regulatory authorities
Summary PSMF for marketing authorisation
A summary of the pharmacovigilance system master file (summary PSMF) and risk management plans are a necessary part of most applications for marketing authorisation. We can help compile and present the required documents completely and efficiently.