The course is applicable for new employees within the pharmacovigilance area. Learn about pharmacovigilance for medicinal products for human use, the current requirements in EU and Denmark, and how they are handled by the pharmaceutical industry, by the authorities and European Medicines Agency (EMA).
The participants will be provided with a basic introduction to the current pharmacovigilance requirements, highlighting responsibilities applicable for both the marketing authorisation holder and the sponsor for clinical trials. Using interactive learning, the participants will be able to explain the purpose and objectives of pharmacovigilance, state important elements of a pharmacovigilance system and demonstrate their connections and interactions to each other.
In this course you will be introduced to:
Senior Database Manager, Diploma in Pharmacovigilance Jette H. Lindgren, ALK-Abello A/S
Deputy EU-QPPV & Drug Safety Adviser Klaus Bitsch-Jensen, ALK-Abello A/S
Today’s requirements and awareness of safety on medicinal products is an important task at any pharmaceutical company; a solid and robust pharmacovigilance system with effective and efficient procedures and processes are needed, to ensure that the benefits of the medicinal product exceed the risks by the greatest achievable margin.
You will be introduced to core elements within a pharmacovigilance system and its quality system and how these elements are described and documented in the Pharmacovigilance System Master File (PSMF).
You will learn how adverse events received from spontaneous sources, clinical trial sources and other solicited sources are to be handled. This includes, among other things, the assessment, evaluation and reporting to competent authorities of Individual Case Safety Reports (ICSRs), signal detection and management, safety risk management and benefit-risk evaluation of a medicinal product.
The role and responsibilities of the marketing authorisation holder towards the pharmacovigilance system and the Qualified Person responsible for Pharmacovigilance (QPPV) will also be covered as well as how audits and inspections of the pharmacovigilance system are conducted.
Course language: English