To enable you to apply your resources on tomorrow's business, we provide to you our Pharma-Resources for the maintenance of your already well-established products.
Services – Pharmacovigilance GVP (Good Pharmacovigilance Practice)
Pharmacovigilance – System:
- Compilation and reworking of a Pharmacovigilance – System
- Compiling and accommodation of all necessary SOP´s
- Training of staff
Literature research and corresponding signal detection
- weekly literature research
- research on authority websites and authority data bases
- signal management
- scientific evaluation of ICSRs and complaints
- processing and electronic reporting of ICSRs.
- consulting services with healthcare professionals (e.g. doctors, nurses, pharmacists) and patients.
- Compilation of Periodic Safety Update Reports (PSUR) and Monitoring of PSUR – Deadlines
- Compilation of Risk-Management-Plan (RMS)