compliance, pharmacovigilance, case management Maria Muchkaeva compliance, pharmacovigilance, case management Maria Muchkaeva

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.

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pharmacovigilance, quality assurance, compliance Maria Muchkaeva pharmacovigilance, quality assurance, compliance Maria Muchkaeva

The Role of IT Department in Pharmacovigilance

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.

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