Overview

This 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 is designed for the intermediate level professional and 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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What you will learn

Structures and processes of a quality system and a pharmacovigilance system
Pharmacovigilance System Master File (PSMF) and Pharmacovigilance Quality Manual requirements, content, and maintenance
Safety Data Exchange Agreements across clinical study programs and post-marketing, including the development, regulatory requirements, and quality oversight
Recommendations for Pharmacovigilance System Inspection Readiness
Design of strategy and methodologies for Risk Based Audits
Corrective and Preventative Action (CAPA) Plan preparation and effectiveness checks

Who should attend?

This program is designed for professionals involved in:

Quality assurance and compliance of the pharmacovigilance system
Pharmacovigilance auditors
Drug safety and pharmacovigilance personnel responsible for compliance, training, pharmacovigilance agreements, and/or pharmacovigilance quality documents
Pharmacovigilance activities at a pharmaceutical company or service provider
Pharmacovigilance personnel who are considering the Pharmacovigilance Quality Management System field as a future career path

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

Learning objectives

At the conclusion of this course, participants should 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 Pharmacovigilance Agreements across clinical study programs and post-marketing
Assess 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
Practice preparing responses to a pharmacovigilance audit and inspection findings

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