返回 Agenda
Part 2: Module 3, Module 4, and Module 5
Session Chair(s)
Jennifer Kane, BSN, RN
Head of Pharmacovigilance
Flexion Therapeutics, 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