Can I read EU Good Pharmacovigilance Practices Module II Pharmacovigilance System Master File en on EtoBox?

EU Good Pharmacovigilance Practices Module II Pharmacovigilance System Master File en by d.khaled.safaa is a document available to read on EtoBox.

What is EU Good Pharmacovigilance Practices Module II Pharmacovigilance System Master File en about?

The document outlines the guidelines for good pharmacovigilance practices (GVP) in the EU, specifically focusing on the pharmacovigilance system master file (PSMF). It details the legal requirements, objectives, and responsibilities of marketing authorization holders regarding the PSMF, including its content, location, and maintenance. The guidelines are set to come into effect in July 2012 following a public consultation period.

Author

d.khaled.safaa

Language

EN