This course on Literature Monitoring in Pharmacovigilance is tailored for those working in drug safety and regulatory affairs. It covers essential skills like literature search techniques and guidance from key regulatory bodies, equipping you to effectively monitor and evaluate scientific literature related to adverse drug reactions. You'll also get practical tools to improve your case processing and signal detection abilities.
What you'll learn
Literature search techniques
Data extraction and analysis
Guidance on literature monitoring from FDA and EMA
Reviewing literature articles
Understanding literature databases
Role of literature in case processing and aggregate reports
Course objectives
To enhance understanding of how to effectively monitor scientific literature for ADRs
To provide practical skills for healthcare professionals in pharmacovigilance