Pharmacovigilance (PV) is a regulatory obligation, but in practice it is often treated as a secondary function until something goes wrong. The Therapeutic Goods Administration (TGA) continues to identify recurring deficiencies across sponsors of all sizes, particularly within listed medicines and complementary products. These findings are rarely due to a lack of intent; more often, they reflect gaps in systems, oversight, and practical implementation

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.

In pharmacovigilance, where data integrity, security, and accessibility are critical, the IT department serves as an essential partner to ensure compliance and smooth operations. IT involvement spans across several key areas, including secure data exchange, system transfers, business continuity planning, and robust system security.