Overview

This beginner to intermediate level virtual live training course will describe contemporary principles, practical approaches, and regulatory expectations for the Pharmacovigilance Quality Management System. The topics will cover organizational structure, responsibilities, processes and resources required for the pharmacovigilance (PV) system and its quality system. The course employs a mixture of informative instructional sessions, real-world case studies, and hands-on interactive exercises where attendees can apply what they learn. Learners will leave the course with an understanding of how elements of the Pharmacovigilance and Quality Management Systems fit together to achieve regulatory compliance.

A working knowledge of drug safety and pharmacovigilance principles is necessary in order to gain maximum benefit from the course.

What participants from the previous virtual QMS course say:

“This course was very great, I enjoyed it a lot! And I will implement some new ideas in my work.”
Ivonne Ramirez, PV Specialist, Boehringer-Ingelheim, Mexico

"Experienced Pharmacovigilance Consultant with a demonstrated history of working in the pharmaceutical industry. A high quality standard in relation to processes and data analysis. Able to act inter- and intradepartmental taken with the focus on teamwork. Acting EU-QPPV. Experienced in case processing, data analysis, EV reporting (ICSRs as well as art57/XEVMPD), compilation of pharmacovigilance system master files (PSMF), initial compilation and maintenance of CCDS and setting up PV systems. EMA and IGJ inspection experience. Eager to transfer knowledge to people in order to make them grow in the field of pharmacovigilance."
Bianca Schrans-Stassen, EU QPPV, Interdos, The Netherlands

“A really excellent oversight. Thoroughly enjoyed the course. The information was valuable, and it is really good to see how your organisation is either aligned with the information shared or whether there are improvements that can be made.”
Sara Santosh Expedith, PV Risk Specialist, Novo Nordisk, UK

Featured topics

What is a Quality System
How to set up a QMS
Exercise on listing the Key/Critical PV activities
Workshop on Gap Analysis of PV processes
Overview and description of the PSMF and PV Quality Manual
Risk Management Workshop
Process Flow Workshop
Safety Management Plans
Exercise on SDEA agreements
Commercial Activities and PV Obligations
Exercise on KPIs/metrics
Risk Assesment Workshop
Record Management, Documentation of QMS and Data Privacy Regulation
PV Inspections and Inspection Readiness
Inspection Findings Response Workshop
Root Cause Analysis Workshop

Who should attend?

This course is designed for professionals involved in:

Quality assurance and compliance of the pharmacovigilance system
Pharmacovigilance auditors
Drug safety and pharmacovigilance personnel responsible for compliance, pharmacovigilance agreements, and/or pharmacovigilance quality documents
Pharmacovigilance activities at a pharmaceutical company or external service provider

Pharmacovigilance personnel who are considering the Pharmacovigilance Quality Management System field as a future career path would benefit from this course.

Learning objectives

At the conclusion of this course, participants will be able to:

Describe how to design, develop, and manage a quality system related to your pharmacovigilance system
Explain the components of the Pharmacovigilance Quality Manual
Describe the process for the development and maintenance of the Pharmacovigilance System Master File
Analyze how the pharmacovigilance quality system integrates with the pharmacovigilance system
Discuss the development, maintenance, and quality oversight of pharmacovigilance SOPs and pharmacovigilance related documents, including Safety Management Plans and PV Agreements across clinical study programs and post-marketing
Evaluate the effectiveness of the Quality Management System
Explain Quality Risk Management Planning for risk-based audits of the Pharmacovigilance System and Quality System
Define the scope of pharmacovigilance audits, including process audits, drug specific pharmacovigilance audits, and business partner pharmacovigilance audits
Describe how to prepare for audits and inspections
Prepare responses to a pharmacovigilance audit and inspection findings

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