European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications Training Course

An Introduction to the New PV Structure

• The new Modules
• The interaction of the Modules
• The EU Modules & ICH

Quality Management Systems (QMS) (Module 1)

• Quality Control, Quality Assurance, and Quality Management
• Quality Management of PV  systems
• The QP PV and Quality Management
• Quality & Training
• QA & Quality Management & internal audits

The Pharmacovigilance Systems Master File (PSMF – Module II)

• The content of the PV Master file
• Licence submissions and the PV Master file
• The QP PV and the PV Master file
• Control/Management of the PV Master file  
• The PSMF/Annexes and Regulatory Inspections

Pharmacovigilance Inspections (Module III)

• The purpose of the Inspection
• Types of Inspection
• Inspection findings
• Re-Inspections

Pharmacovigilance Audits (Module IV)

• The purpose of Company audits
• Audit scheduling and risk assessments
• Audit outputs and findings
• Audit findings and their corrections – Root Cause Analysis, Corrective Action Plans, Completion and re-audits/scheduling

Risk Management Plans (RMPs – Module V)

• ICH E2E – Pharmacovigilance Planning
• The RMP purpose in Europe
• The RMP format – Generic products v Innovator
• Updating the RMP
• RMPs & REMs

Adverse Reaction Reporting – Part 1 (Module VI)

• Definitions
• Special Situations
• IMEs and DMEs
• Triage – Seriousness
• Expectedness and Causality
• Expedited reporting (including Country specific v EMA)

Adverse reaction Reporting – Part 2 (Module VI)

• Electronic ADR reporting local & International
• Follow up of cases
• ICH E2D – Post Marketing Safety
• Literature ADR reporting
• Case Closure

PBRERs (Module VII)

• ICH E2F & ICH E2C (R2) – DSURs & PSURs/PBRERs
• Objectives of the PSURs
• Risk Benefit Analyses in PSURs
• The format of the PSUR
• Mapping Signals and Risks to the PSUR

Signals and their Management (Module IX)

• What is a signal?
• Signal Scheduling
• Signal validation
• Signal analysis and prioritisation
• Signal Assessment
• EVDAS and signalling
• Actions to be taken

Post-Authorisation Safety Studies (PASS) (Module VIII & Addendum)

• The need for PASS
• The design of the PASS
• Results from the PASS & RMPs
• Post Authorisation Efficacy Studies

Additional Monitoring (Module X)

• The purpose of additional monitoring for products
• What needs to be done?
• Mandatory & Optional aspects of additional monitoring
• The role of the MAH in additional monitoring

Risk Minimisation (RM) Measures and Tools

• RIsk Minimisation measures
• Educational Tools
• Controlled Access programmes
• Other RM techniques

Urgent Safety Restrictions & Safety Communications (Modules VI, IX and XV)

• Safety Communications to the Regulatory Authorities
• Process for Urgent Safety Restrictions
• What Safety Communication and where
• Approval and Monitoring of Safety Communications

The EU QP PV & Local (National) QP PVs – Modules I & II – Knowledge & Oversight

• The roles and responsibilities of the EU QP PV
• Knowledge of the EU QP PV
• The EU QP PV and Regulatory Inspections
• The EU QP PV & Local (QP PVs/Responsible Person)
• Brexit – The UK QP PV