DUBLIN–(BUSINESS WIRE)–The “Demystifying European Post-Marketing Pharmacovigilance Training Course (Nov 3rd – Nov 7th, 2025)” training has been added to ResearchAndMarkets.com’s offering.
This course provides a comprehensive overview for senior managers of the key post-market pharmacovigilance activities required to further understand the 2012 EU legislation that 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 and information 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 the UK Brexit implications will be discussed.
Who Should Attend:
This course is intended for senior management professionals from European and US pharmaceutical companies, who need to understand EU Pharmacovigilance. It will be particularly 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, including the UK Brexit implications.
All of these activities are discussed in relation to Quality Management Systems (QMS), audits and inspections.
Benefits of attending
- Explore how the safety of products is managed at the regulatory authority level, the interactions with regulatory bodies and pharma
- Learn 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
- Discuss The European Medicines Agency (EMA) and the Pharmacovigilance Risk Assessment Committee (PRAC) deliberations and Brexit implications
Certifications:
- CPD: 18 hours for your records
- Certificate of completion
Key Topics Covered:
Day 1
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
Day 2
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
Day 3
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
Day 4
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
Day 5
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
Speakers:
Graeme Ladds
Director
PharSafer Associates Ltd.
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he 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.
For more information about this training visit https://www.researchandmarkets.com/r/d0xts4
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