What Is A Pharmacovigilance System Master File (PSMF) And Can It Be Outsourced?

Описание: What Is A Pharmacovigilance System Master File (PSMF) And Can It Be Outsourced? In this informative video, we will cover the Pharmacovigilance System Master File (PSMF) and its importance in the pharmaceutical industry. The PSMF is a key document that outlines how companies manage the safety of their medicinal products. We will discuss its role in monitoring and evaluating adverse effects, as well as the organizational structure and processes involved in pharmacovigilance.

You will learn about the regulatory requirements surrounding the PSMF, particularly within the European Union, where it is mandatory for companies to maintain this document. We will explain the significance of keeping the PSMF updated and how it must be readily available for inspection by regulatory authorities.

Additionally, we will address the possibility of outsourcing the creation and maintenance of a PSMF. Many companies opt for specialized service providers to ensure compliance with regulations. However, it is essential to understand that the Marketing Authorization Holder remains responsible for the accuracy and availability of the PSMF, even when outsourcing.

Join us for this enlightening discussion, and subscribe to our channel for more essential information on pharmacovigilance and medication safety.

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