Day 1 – Tuesday 10th May

Regulations and Regulators

Session 1.1 Legislative & regulatory background

• Overview of the key legislation and guidance that govern PV inspections and audits from EU, USA and rest of world
• Understand the basic process steps

Session 1.2 Inspection updates from FDA, EMA & MHRA

• Examples of findings during inspections
• Changing pattern of inspection findings
• Current regulatory expectations

End of day discussion topic: Expectations for inspection of risk management and PSURs

Day 2 – Wednesday 11th May

Planning and Preparation

Session 2.1 Audit Planning & conduct

• Defining the audit strategy
• What is your audit ‘universe’?
• Remote auditing

Session 2.2 Inspection preparation

• PSMF maintenance
• QMS support of PV activities
• Interviewee readiness

End of day discussion topic: Inspectors expectations for pharmacovigilance in Patient Support Programmes – latest from MHRA / FDA

Day 3 – Thursday 12th May

Conduct and Follow-up

Session 3.1 Inspection Conduct,

• Communicating with Inspectors,
• Recommendations, practical hints & tips

Session 3.2 Post-inspection Activities

• Reporting
• Responding to findings
• Actions and follow-up

End of day discussion topic: Latest challenges in PV – how to remain inspection ready in a changing world