The Pharmacovigilance Quality Management System
This beginner to intermediate level 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 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 (PV 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, 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.
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