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.

The Medical Affairs department plays a crucial role in ensuring the safety of medicines and therapies throughout their lifecycle. While traditionally seen as a bridge between clinical research and the commercial arm of a pharmaceutical company, Medical Affairs also has an essential function in pharmacovigilance (PV). This responsibility arises because of the department’s close contact with healthcare professionals (HCPs), patients, and key opinion leaders (KOLs), which makes it a critical source of post-market safety information.

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.

Organised Data Collection Systems (ODCS) are essential to pharmacovigilance, ensuring systematic, comprehensive, and reliable data collection to monitor and improve drug safety.

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.

Not all sunscreens are created equal, and ensuring their safety and efficacy falls under the purview of the Therapeutic Goods Administration (TGA).

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.