A Qualified Person for Pharmacovigilance (QPPV) is a regulatory requirement in the European Union (EU) for pharmaceutical companies involved in the marketing and distribution of medicinal products.

An audit of a pharmacovigilance (PV) department is a critical exercise to ensure that the department operates in compliance with regulatory requirements and follows best practices for monitoring and managing drug safety.

The process of bringing a drug from the laboratory to the market is complex and highly regulated. Preparing regulatory packages, interacting with regulatory agencies, and post-launch compliance are critical stages to ensure the safety and efficacy of the product.