Responsible Person for PharmacoVigilance (RPPV)

The Qualified Person for Pharmacovigilance (QPPV) is a key role in the field of drug safety and regulatory compliance. The QPPV is responsible for overseeing the pharmacovigilance system of a pharmaceutical company or a marketing authorization holder, ensuring that all adverse events and safety issues related to their products are effectively monitored, evaluated, reported and managed in compliance with relevant regulations.
The QPPV acts as the main point of contact between the company and regulatory authorities, providing oversight and guidance to their team of pharmacovigilance professionals. They are responsible for ensuring the safety of the company’s products throughout their lifecycle, from clinical trials to post-marketing surveillance.
The QPPV must have a thorough understanding of the company’s products and the regulations governing their use, as well as the ability to effectively communicate safety information to both internal and external stakeholders. They must also maintain a continuous monitoring of safety data and emerging safety concerns, and ensure that appropriate actions are taken in a timely manner to protect patient safety.
In China the similar role is named Responsible Person for Pharmacovigilance (RPPV). The main scope, responsibility, and regulatory requirement of RPPV is illustrated in China GVP.
See also Comparison of EU-QPPV and China RPPV Section for more detailed China RPPV requirement.
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