UNIT 12: Special Scenarios in Pharmacovigilance
This unit covers special pharmacovigilance scenarios that require focused evaluation due to higher risk, regulatory sensitivity, or unique data handling requirements. It explains how safety is assessed and reported for special populations, product types, and situations where standard PV approaches need adaptation.
Special situations in pharmacovigilance refer to scenarios where medicine exposure occurs under conditions that require additional attention, documentation, or follow-up beyond routine adverse event reporting. These situations may or may not involve an adverse event but are important due to potential safety implications.
Key Points
May be reportable even without an adverse event.
Require careful documentation and follow-up.
Have increased regulatory and clinical relevance.
Explore Our Courses
Master life sciences with comprehensive courses in regulatory science, clinical research, and pharmacovigilance.
How was this unit?
Your feedback helps us improve our content
Don't just guess—prove it! Take a quick MCQ test to challenge your understanding and boost your retention.