The Good Pharmacovigilance Practice - Inspection and Audits is a webinar that covers topics such as:
- The Pharmacovigilance Audit
- Regulatory Background
- Need for oversight of the pharmacovigilance system
- Importance of QPPV in Europe
- Suitability of people
- Ensuring information on adverse events is accessible
- Processing of ICSRs
- Requirements for SOPs
- Periodic Safety Update Reports (PSURs)
- Electronic reporting
- Quality assurance
- Signal detection practical tips
The Good Pharmacovigilance Practice - Inspection and Audits brings together Regulatory Affairs, Drug safety and pharmacovigilance and Clinical development.
