戻る Agenda
Part 2: Module 3, Module 4, and Module 5
Session Chair(s)
Angela Pitwood, BSN, MBA, RN
Vice President
WCG Clinical | Vigilare, United States
Module 3 – MHRA/EMA/EU Inspections
- Qualified person for PV
- Preparation
- The Good PV Practices Inspection Module
- Types of findings
- Pharmacovigilance System Master File
Module 5 - Responding to the Findings and Preparing the Corrective and Preventive Actions (CAPA)
- Theresponse
- CAPA
Questions/Answers