In this course you will learn about vaccine safety surveillance in the EU region. This is introductory level, where basic requirements, standards and vaccine pharmacovigilance activities are discussed. Vaccines quality, safety and efficacy should be proved throughout the lifecycle of the product, so pharmacovigilance activities are focused on maintaining high standards and continuous monitoring of all mentioned characteristics. In a simple way you will gain knowledge about:

• Collection and assessment of safety information
• AEFI, different types of AEFI and how to report it
• Why safety assessment is different for vaccines
• Legislation process and roles in EU
• Key regulations and guidelines in EU and how central legislation translates into local
• Roles of different stakeholders and their responsibilities
• Methods for safety and efficacy assessment and monitoring (for example PASS, PAES or signal management)
• Special considerations for vaccines

There is also comprehensive review of quality system throughout the lifecycle of the vaccine (both pre-marketing and post-marketing stages). Moreover some epidemiological aspects are described as they related to mass vaccination. Vaccines are administered to large populations as part of vaccination programs and a separate analysis should be performed including not only safety assessment, risk-benefit profile or other medical knowledge, but also economic, social and geographic criteria.

There are couple of activities that will strengthen you understanding of vaccine pharmacovigilance system. This course will be a foundation for further exploration of vaccine safety surveillance topic.