How to ensure an Effective Quality System for Pharmacovigilance Activities?

“Quality” is one of the key areas in drug safety and pharmacovigilance (PV). It consists of quality planning, quality control, quality assurance and quality improvements which are crucial for ensuring correct analysis and undertaking corrective actions in a timely manner and helps to safeguard the health of the patients and allows safe use of the drug.

Both FDA and EMA (and other agencies) have made it clear that they expect the quality to be built into drug safety (and all pharmaceutical systems) by releasing guidance and good practices.

Hence, in each PV unit a quality management system must be implemented including a quality policy, approved standard operating procedures (SOPs), quality control (QC) procedures, key performance indicators (KPI), jobs description and training plans should be in place covering the entire PV process. This quality management system has to ensure that all PV activities are conducted in conformity with the highest ethical standards and relevant regulatory requirements and contractual obligations to any partners.

That’s what we will discuss in our monthly webinar with our Expert guest. See you then!