Developing and maintaining a functional and compliant pharmacovigilance system cannot be possible without having an understanding of the building blocks of drug safety at different levels. Our programs cover from basic concepts to pragmatic applications to advanced theories. We design and deliver customized workshops, classroom or electronic trainings that include:

• MedDRA terminology support (event coding, QC, coding conventions)
• Data retrieval
• Medical review and Causality assessment
• Seriousness and Labeling assessment
• Auto-labeling
• Role of narratives
• Inspection readiness
• Definitions in Risk management
• Preparation of expert statements, RMPs, and responses to Health Authorities

We also provide customized training programs for clinical trial investigators as part of Investigator Meetings. For the best possible knowledge transfer these are delivered by physicians and focus on seriousness and causality assessment as well as follow up activities and reporting compliance.