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 and ICH

Quality Management Systems (QMS)

• 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)

• 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 audits

• 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

Adverse reaction reporting – part 1

• Definitions
• Special situations
• IMEs and DMEs
• Triage – seriousness
• Expectedness and causality
• Expedited reporting (including country specific v EMA)

Adverse reaction reporting – part 2

• Electronic ADR reporting local & international
• Follow up of cases
• ICH E2D – post marketing safety
• Literature ADR reporting
• Case closure

PBRERs

• 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

Post-authorisation safety studies (PASS)

• The need for PASS
• The design of the PASS
• Results from the PASS & RMPs
• Post-authorisation efficacy studies

Additional monitoring

• 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

Urgent safety restrictions and safety communications

• 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 and Local (National) QP PVs

• 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

Pharmacovigilance inspections

• The purpose of the inspection
• Types of inspection
• Inspection findings
• Re-inspections

Risk management plans (RMPs)

• ICH E2E – pharmacovigilance planning
• The RMP purpose in Europe
• The RMP format – generic products v innovator
• Updating the RMP
• RMPs & REMs

Risk minimisation (RM) measures and tools

• Risk minimisation measures
• Educational Tools
• Controlled access programmes
• Other RM techniques

Signals and their management

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