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.

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

Participant Testimonials

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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Pharmacovigilance Quality Management System

Overview

Participant Testimonials

Featured topics

Who should attend?

Learning objectives

Digital Learning Catalog

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