Description
The Good Pharmacovigilance Practice Guide highlights the areas in which inspection findings are commonly found and provides specific examples of good or poor practice. This assists organisations in developing effective pharmacovigilance systems. It complements EU legislation and guidance and provides practical advice about achieving an appropriate system of pharmacovigilance.
The book includes:
- roles and responsibilities of the EEA Qualified Person for Pharmacovigilance
- managing case reports and other safety information
- ongoing evaluation of safety data
- quality management aspects of pharmacovigilance
- managing contracts and agreements
- pharmacovigilance beyond the drug safety department
