With the increased global scrutiny and emphasis on signal detection and risk management, marketing authorization holders must find ways to harmonize the clinical coding of medical terms relating to medical conditions, medicines, and medical devices.
This white paper looks at the importance of moving to a predictive and proactive pharmacovigilance environment, with clear and accurate coding to monitor drug safety throughout the product lifecycle.
- Coding challenges – Achieving accurate and consistent coding aligned with a globally standardized medical dictionary, MedDRA , has many challenges, including the time-consuming process of upgrading dictionary versions and waiting too late when a periodic report is due to address coding inconsistencies
- End-to-end processes – Adopting clear, consistent coding conventions, centralizing coding between clinical and safety, having an internal review board manages new releases of MedDRA, having a defined process for upgrading, and ensuring collaboration between business and IT
- End-to-end technologies – Have a centralized coding tool that can carry out batch coding and can automate many tasks, that will flag and address inconsistencies, and harmonize data and coding.