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

2022-10-25

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.

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

Speaker

Graeme Ladds

Director

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.

For more information about this conference visit https://www.researchandmarkets.com/r/xvi8pk

Media Contact:

Research and Markets

Laura Wood, Senior Manager

[email protected]

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SOURCE Research and Markets