Follow-ups in PV: A Guide for Effective Case Management
In pharmacovigilance, follow-ups are crucial for gathering comprehensive and accurate data on adverse events associated with pharmaceutical products. In Australia, where pharmacovigilance standards align with stringent Therapeutic Goods Administration (TGA) requirements, follow-up procedures are structured to ensure timely, detailed, and effective case assessments, particularly for special cases like pregnancy reports. This article explores how to conduct effective follow-ups in pharmacovigilance, detailing the specific requirements, techniques for data collection, and specialised guidance for handling pregnancy cases.
Organised Data Collection Systems (ODCS) in Pharmacovigilance
Organised Data Collection Systems (ODCS) are essential to pharmacovigilance, ensuring systematic, comprehensive, and reliable data collection to monitor and improve drug safety.
Event Coding in Pharmacovigilance (PV)
Event coding in PV stands out as a critical process. A systematic and standardised approach to coding adverse events and medical terms is essential for efficient signal detection, risk management and regulatory reporting.