DUBLIN, Oct. 25, 2022 /PRNewswire/ -- The "European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications Training Course" conference has been added to
ResearchAndMarkets.com'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. 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.
An Introduction to the New PV Structure
The interaction of the Modules
Quality Control, Quality Assurance, and Quality Management
Quality Management of PV systems
The QP PV and Quality Management
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
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
ICH E2E - Pharmacovigilance Planning
The RMP purpose in Europe
The RMP format - Generic products v Innovator Adverse Reaction Reporting - Part 1 (Module VI)
Expectedness and Causality
Expedited reporting (including Country specific v EMA)
Adverse reaction Reporting - Part 2 (Module VI)
Electronic ADR reporting local & International
ICH E2D - Post Marketing Safety Risk Benefit Analyses in PSURs
Mapping Signals and Risks to the PSUR
Signals and their Management (Module IX)
Signal analysis and prioritisation
Post-Authorisation Safety Studies (PASS) (Module VIII & Addendum)
Results from the PASS & RMPs
Post Authorisation Efficacy Studies
The purpose of additional monitoring for products
Mandatory & Optional aspects of additional monitoring
The role of the MAH in additional monitoring
Risk Minimisation (RM) Measures and Tools
RIsk Minimisation measures
Controlled Access programmes
Urgent Safety Restrictions & Safety Communications (Modules VI, IX and XV)
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)
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. For more information about this conference visit https://www.researchandmarkets.com/r/xvi8pk
Laura Wood, Senior Manager
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
Fax (outside U.S.): +353-1-481-1716
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