European post-marketing pharmacovigilance training course (2-4 November 2022)

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Dublin, Oct. 17, 2022 (GLOBE NEWSWIRE) — The ‘European Post Marketing Pharmacovigilance – Including EMA/PRAC Deliberations and Brexit Implications Training Course’ conference has been added to from offer.

This course provides a comprehensive overview of the main post-marketing pharmacovigilance activities needed to better understand the new EU legislation introduced in 2012 and which has undergone more than 20 updates over the past 10 years.

The course aims to show how product safety is managed at the regulatory authority level, interactions with regulators and pharmacy, and internal pharmacy processes in managing company product safety from receiving safety cases/information, all the way through to signal analysis and safety communication. All of this is considered from a practical standpoint for compliance and key performance indicators (KPIs).

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

Who should attend:

This 3-day course is intended for people from Europe and the United States who need to understand EU pharmacovigilance. It will be beneficial for those working in related technical areas (regulatory, clinical, quality assurance and audit) who need an overview of key pharmacovigilance activities and also need to understand the many complexities of EU pharmacovigilance. All of these activities are addressed in relation to Quality Management Systems (QMS), audits and inspections.

Main topics covered:

An introduction to the new photovoltaic structure

Quality Management Systems (QMS) (Module 1)

  • Quality control, quality assurance and quality management

  • Quality management of PV systems

  • QP PV and Quality Management

  • Quality & Training

  • QA & Quality Management & Internal Audits

The Pharmacovigilance Systems Master File (PSMF – Module II)

  • The contents of the PV Master file

  • License Submissions and PV Master File

  • The QP PV and the master PV file

  • PV Master File Control/Management

  • The PSMF/Appendices and Regulatory Inspections

Pharmacovigilance inspections (Module III)

Pharmacovigilance audits (Module IV)

  • The purpose of business audits

  • Audit planning and risk assessment

  • Audit outputs and findings

  • Audit Findings and their Corrections – Root Cause Analysis, Corrective Action Plans, Completion and Re-Audits/Scheduling

Risk Management Plans (RMP – Module V)

  • ICH E2E – Pharmacovigilance planning

  • The RMP objective in Europe

  • The RMP Format – Generics v Innovator

  • RMP update

  • RMP and REM

Adverse Reaction Reporting – Part 1 (Module VI)

Reporting of Adverse Reactions – Part 2 (Module VI)

RPEAR (Module VII)


  • Objectives of PSURs

  • Risk-benefit analyzes in PSURs

  • The format of the PSUR

  • Mapping signals and risks at the PSUR

Signals and their management (Module IX)

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

Additional Monitoring (Module X)

  • The subject of additional product monitoring

  • What needs to be done?

  • Mandatory and optional aspects of additional supervision

  • The role of the marketing authorization holder in additional monitoring

Risk minimization (RM) measures and tools

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

  • Safety Communications to Regulators

  • Process for urgent security restrictions

  • What safety communication and where

  • Security Communications Approval and Monitoring

The EU PV QP and the local (national) PV QPs – Modules I and II – Knowledge and Supervision

  • The roles and responsibilities of the EU QP PV

  • Knowledge of EU QP PV

  • EU QP PV and regulatory inspections

  • 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 of experience in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety and Medical Information, Graeme later became Head of Global Pharmacovigilance at Shire Pharmaceuticals.

The last 11 years have been spent at his consulting company, PharSafer Associates Ltd. During this time, Graeme has been involved in setting up pharmacovigilance in companies, conducting audits in Europe and the US, writing SOPs, quality QPs for companies and assistance with regulatory controls.

For more information on this conference, visit

CONTACT: CONTACT: Laura Wood,Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

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