69.00€
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:
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.
I am PV specialist, but also PV trainer. I studied biotechnology and I gained master degree in chemical biotechnology – drugs and cosmetics development. After graduation It was important for me to acquire the knowledge about all steps that are involved in the product development from the laboratory to the product being on the market, so during my carrier I took the opportunity to gain experience in different areas like R&D, manufacturing, marketing and educational programs. I’ve started my PV journey about 5 years ago, right now I am Training and Education Manager and my role joins both areas of interest which is PV and education. I am also member of PTBFarm – Polish Polish Society of Pharmacovigilance In my trainings I apply the same approach I have mentioned above – I think that to understand your role better, you need to learn about the entire process and other roles in the “ecosystem”. I always try to arouse interest in individual exploration of presented topic and give you necessary tools. Therefore, I hope to pass on the knowledge in my class but also prompt your further development. See you in the training!
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