European Post Marketing Pharmacovigilance Training Course (November 2-4, 2022)


Dublin, Oct. 17, 2022 (GLOBE NEWSWIRE) -- The "European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications Training Course" conference has been added to's offering.

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.

The course intends to show how the safety of products is managed at the Regulatory Authority level, the interactions with Regulatory Bodies and Pharma, and the internal Pharma processes in managing the safety of the Company products from receiving safety cases/information, all the way through to signal analysis and safety communication. All of this is viewed from a practical point of view for compliance and Key Performance Indicators (KPIs).

The European Medicines Agency (EMA) and the Pharmacovigilance Risk Assessment Committee (PRAC) deliberations and Brexit implications will be discussed.

Who Should Attend:

This 3-day course is intended for those individuals from Europe and the USA, who need to understand EU Pharmacovigilance, it will be beneficial for those working in allied technical areas (Regulatory, Clinical, QA, and Auditing) who require an overview of key pharmacovigilance activities and also need to understand the many complexities of EU pharmacovigilance. All of these activities are discussed in relation to Quality Management Systems (QMS), audits and inspections.

Key Topics Covered:

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


Graeme Ladds
PharSafer Associates Ltd.

Graeme Ladds, Director of PharSafer, has over 22 years' experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.

The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

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