The Pharmacovigilance Quality Management System On-Demand Training
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The Pharmacovigilance Quality Management System
This beginner to intermediate level on-demand training course will describe contemporary principles, practical approaches, and regulatory expectations for the Pharmacovigilance Quality Management System.
Credit Information
9.25 ACPE
.9 IACET
.9 IACET
Description
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 recorded 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