Pharmacovigilance systems
With the amendments made to the German Drug Law (AMG) in recent years, the requirements for monitoring drug safety using a pharmacovigilance system have become much more formalised. The qualified person for pharmacovigilance is responsible for establishing and maintaining a pharmacovigilance system at their respective company.We act in this capacity for pharmaceutical companies, relieving them of the associated time, effort and expense, performing, among others, the following services:
- Evaluation of existing pharmacovigilance systems (SOPs, literature research, reporting, PSURs, alarm plans, etc.) and measures to minimise risk
- Establishing pharmacovigilance systems and compilation of risk management plans (RMP) that are based on standardised procedures for human and veterinary medicinal products
- Individualised implementation into the company, employee training
- Conducting internal audits
- Preparation for and assistance with inspections by regulatory authorities
The detailed description of the pharmacovigilance system (DDPS) and risk management plans are a necessary part of most applications for marketing authorisation. We can help you to compile the required documents.
Contact us!
