Presented by
Management Forum
European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications Training Course
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.
6-10 November 2023
from £1349
- Format: Live online
- Pharmacovigilance
- Understanding Pharmacovigilance Regulations in APAC
- Advanced Pharmacovigilance
- Pharmacovigilance Aspects of Licensing Agreements
- An Essential Overview of Pharmacovigilance
- Practical Requirements of the Arab Pharmacovigilance Guidelines
- Pharmacovigilance QMS & Inspection Preparation
- European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications
- Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge
Overview
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 course is part of our Vigilance Training Course collection, which features other pharmacovigilance training courses for professionals.
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.
The European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications course will cover:
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 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
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
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
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
Pharmacovigilance Inspections (Module III)
- The purpose of the Inspection
- Types of Inspection
- Inspection findings
- Re-Inspections
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
Risk Minimisation (RM) Measures and Tools
- RIsk Minimisation measures
- Educational Tools
- Controlled Access programmes
- Other RM techniques
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
Graeme Ladds
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.
Book European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
6-10 November 2023
Live online
13:00-16:55 UK (London) (UTC+00)
14:00-17:55 Paris (UTC+01)
08:00-11:55 New York (UTC-05)
Course code 12794
- GBP 1,349 1,649
- EUR 1,939 2,359
- USD 2,201 2,669
Until 02 Oct
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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
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