About course
This course is a practical introduction to the management of Individual Case Safety Reports (ICSR) in European Union. If you are in the beginning of your professional career in pharmacovigilance or just want to improve you knowledge about ICSR management, then this is the course for you. This course will give you all the tools to get started with case management.
What you will learn in this course?
- Basic definitions and terms used by safety specialists on a daily basis
- Assessment of case validity
- Reporting requirements in the European Union
- Structure of Eudravigilance database
- Reporting timelines in the pre- and post-authorization phases
- Different types of safety reports
- Special scenarios considered in ICSR management
- Special population in case management
- Management of literature screening
- When the Marketing Authorisation Holder should consider the product as its own
- Main responsibilities of Marketing Authorisation Holders and Competent Authorities
- Management of significant and non-significant follow-up information
- Management of report amendment and nullification
Competences covered by this course
By attending this course, you will learn
- Definition of active substance, excipient, medicinal product, adverse event, adverse reaction, causality, primary source, medical confirmation, suspect, concomitant and interacting drug
- Definition of ICSR and minimum validity criteria for ICSR
- Definition of serious adverse reaction, seriousness criteria and difference between seriousness and severity
- Definition of SUSAR and its submission timelines
- Basics about reporting of AEs
- Key stages for ICSR management and quality management requirements
- Purpose and structure of EudraVigilance
- ICSR submission timelines
- Different types of safety reports and how they are classified
- Use of the product outside the terms of the marketing authorization
- Management of occupational exposure, exposure during pregnancy and breastfeeding reports
- Management of lack of efficacy reports
- Management of suspected transmission via a medicinal product of an infectious agent and suspected adverse reactions related to quality defect or falsified medicinal product
- Screening and management of literature reports
- When Marketing Authorisation Holder should consider the product as its own?
- Responsibilities of Competent Authorities and Marketing Authorization Holders
- Management of significant/non-significant follow-up reports
- Management of report amendment and nullification
Few words from Course SME
Aleksandra is a pharmacist with many years of experience in pharmacovigilance. After graduating, she joined Pfizer as a Junior Safety Data Management Specialist working in the Hub supporting all European countries, Middle East and Africa where she gained experience in case processing activities, triage and acceptance of reports coming from Eudravigilance database and submission to Ethics Committees and Investigators. Currently she manages a team of safety specialists.
Along with her weak spot for the literature cases she is also keenly interested in signal detection.
Passionate about further broadening of her knowledge she regularly participates in numerous trainings, e.g. ‘Signal and Risk Management in Pharmacovigilance MasterClass’ in November 2020, organized by Global Leading Conference, ‘Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors’ in May 2022, postgraduate studies “Management and Monitoring of Clinical Trials” in 2019 at Kozminski University.
Knowing that her work has an impact on health and safety of patients is the greatest motivation and gives her a lot of satisfaction.
When she is not working you can usually meet her cycling or playing squash. She is also interested in learning different languages as they help her to explore new cultures around the world.
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