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

Top 10 Pharmacovigilance Deficiencies Identified by the TGA (and How to Avoid Them)

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

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pharmacovigilance, vendor management Maria Muchkaeva pharmacovigilance, vendor management Maria Muchkaeva

Vendor Qualification and Management

Pharmaceutical companies often rely on various external vendors to support activities such as adverse event reporting, safety data processing, and regulatory intelligence. This responsibility extends beyond traditional vendors to include entities such as social media influencers and market research organisations (MROs) that may receive and process safety information. Ensuring that these vendors meet rigorous standards for quality, compliance, and data integrity is essential for maintaining the safety and efficacy of medicinal products.

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

Quality Assurance Department in Pharmacovigilance

In the pharmaceutical industry, ensuring the safety and efficacy of drugs is paramount. This responsibility is shared between various departments, with Quality Assurance (QA) and Pharmacovigilance (PV) playing crucial roles. While Pharmacovigilance focuses on monitoring and assessing adverse drug reactions, the QA department ensures that the processes involved in drug production and monitoring meet stringent quality standards. The intersection of these two functions is critical for maintaining drug safety and regulatory compliance.

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