A System Approach to Good Pharmacovigilance Practice

Description

In today's evolving landscape, pharmacovigilance (PV) systems face ongoing challenges due to global, national, and company-specific events. This course focuses on developing personnel equipped to navigate these complexities and improve the safe use of medicinal products.

We emphasise continuous global thinking, communication, and strategic planning, ensuring adaptability across various levels. The course explores maintaining PV system functionality while adhering to regulatory requirements.

Participants will apply European regulatory standards to enhance and sustain PV system effectiveness, contributing to improvement initiatives and ensuring operational integrity.

The course covers PV system intricacies, regulatory compliance, and a 'systems approach' for auditors, quality assurance personnel, and PV practitioners. Through presentations and workshops, attendees gain insights into implementing and maintaining an effective PV system.

Throughout the course delegates will explore application of the legal requirements for the PV system and quality system and how to assure these systems. They will demonstrate their ability to contribute to:

Tutors will be comprised of (click the photos for biographies):

Head of PV Department, IVIGEE Services a.s.

Please note timings may be subject to alteration.

Welcome, registration, course objectives and introduction to work groups

Housekeeping notices, meet other delegates, explore how to work in your work group, course objectives. Clarify the definition and objectives of Pharmacovigilance.

The Regulatory Framework for Pharmacovigilance

Identify the relevant regulations and directives. Explore GVP guidance, structure of the modules and standard format of each module.

The Pharmacovigilance System

Exploration of how to organise what has to be done, communications. Exploration of the structures and processes for pharmacovigilance.

Break

Workshop 1 and Feedback

Exploring an organisational model of the pharmaceutical company- cooperation between PV and other stakeholders.

The Quality System for pharmacovigilance

Exploration of the structures, processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently.

Lunch

Workshop 2 and Feedback

The quality system puzzle. Explore the organisation of the PV quality system and how it interacts with the PV system.

The Quality System for pharmacovigilance

Exploration of the structures processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently.

Description of PV System

Break

Workshop 3 and Feedback

The quality system puzzle Explore the organisation of the PV quality system and how it interacts with the PV system.

The Pharmacovigilance Safety Master File

Construction of the Pharmacovigilance System Master File and its purpose.

Workshop 3 and Feedback

Description of PV System.

End of Day

Drug Safety in the Clinical Trial Environment - Part 1

Information flow and responsibilities of the sponsor.

Workshop 4 and Feedback

Drug Safety in the Clinical Trial environment: Information flow and responsibilities of the sponsor.

Break

Drug Safety in the Clinical Trial Environment - Part 2

Information flow and responsibilities of the sponsor.

Lunch

Workshop 5 and Feedback

Drug Safety in the clinical trial environment: Information flow and responsibilities of the sponsor.

Processing of Safety Data

Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management.

Break

EudraVigilance

Exploration of how EudraVigilance supports the PV system.

Signal Detection and Evaluation/Risk Benefit Assessment: Pharmacovigilance Risk Assessment Committee (PRAC):

What is a signal? What are the regulatory requirements? How is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection. Risk benefit assessment.

Risk Management Plans

A cornerstone of Pharmacovigilance safety communications, direct healthcare professional communication

End of Day

The Pharmacovigilance Risk Assessment Committee (PRAC)

Exploration of how good practice is achieved. Composition, role and responsibilities. Examples of referrals.

Development Safety Update Reports (DSURs):

Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution.

Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs)

Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution.

Break

Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs)

Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution.

Workshop 6 and Feedback

To explore the compilation and submission of the PSUR.

Lunch

Role of the QPPV

Exploration of the legal responsibilities of the QPPV and the MAH.

Break

Workshop 7 and Feedback

To explore the challenges faced by the QPPV.

End of course

Face-to-Face Course

This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.

Please note this course will run in UK timezone.

You will need a stable internet connection, a microphone and a webcam.

23 Points

Develop