Global Forum for Qualified Person for Pharmacovigilance (QPPV)

Topics

• Risk Minimisation – Medication beliefs and behaviours, EU requirements
• Two years later – Impact of the new EU PV requirements on the QPPV role
• Networks and Communication – Sources of information for QPPVs
• Metrics and KPIs – Support for QPPV oversight
• Quality Systems – Compliance with GVP Module 1
• Being a QPPV in Different Environments (non- EU companies, contract QPPVs etc.)
• Operational Challenges; e.g. the PSMF, in place and meeting Regulator needs?
• PV Inspections – What’s new and what’s old (but still being found…)

Who should Attend

• Deputy Qualified Persons for Pharmacovigilance
• EEA Qualified Persons for Pharmacovigilance
• CRO and Consultants providing QPPV Services
• Senior Pharmacovigilance Regulators and Inspectors
• Quality Management
• National Responsible Persons for Pharmacovigilance
• Heads of Pharmacovigilance