As of 2012, the “gold” standard of pharmacovigilance (PV) and adverse event (AE) reporting on a global level is based on the European Medicines Agency (EMA) PV Modules, which require that Quality Assurance (QA) be part of the quality management system (QMS), and that PV audits be performed at various levels and at varying sites. Although most Good Clinical Practice (GCP) experts are familiar with pre-marketing drug safety, there is a difference to post-marketing PV and the associated activities.
This is an introductory course for those unfamiliar with the EMA PV Modules or global reporting requirements The basics of EMA (and FDA) expectations on the receipt, processing, reporting, and management of AEs for marketed products (drug and device), and how to prepare for auditing these systems will be presented. Learners will be shown the basic concepts of reportable events, timelines of reporting, what the global PV department is responsible for, and the audit process to be applied for both systematic internal audits as well as at affiliated offices and PV vendors. The course will include presentations, discussions, and problem solving techniques using case studies applicable to both drug and device marketed products. Exercises are designed to help you understand what the PV process actually is and how to apply an auditing perspective.
Take advantage of our $1,595.00 price by registering early! * After March 16, costs are $1,795.00.