PSMF is a detailed description of the Pharmacovigilance (PV) system used by the marketing authorisation holder (MAH) with respect to one or more authorised medicinal products. The PSMF is a legal requirement – it is required for all medicinal products authorized in the EU, irrespectively of the registration procedure and all MAHs, irrespectively of their organizational structure. The structure of the PSMF is strictly controlled by the guidelines of the GVP: Module II. The PSMF must contain specific sections with details of the pharmacovigilance system. Would you like to know more? If so, please join the course!
By attending this course, you will learn:
- How to understand of key PSMF concepts
- About the key regulations and guidelines for the PSMF
- About the roles and responsibilities of the various entities involved in the management of the PSMF
- Basic theoretical knowledge of PSMF
- About the purpose and scope of the PSMF
- How to apply the concepts, principles, methods and tools in practice, while independently performing tasks related to the management of the PSMF
- About the structure of the PSMF, the PSMF template, the level of detail of the information required by the PSMF, the process of preparing the annexes and the PSMF logbook
- How to prepare individual PSMF sections (EU QPPV, safety data sources, IT and databases, safety processes, audits, company quality system)
- About examples of typical PSMF inspection findings and deficiencies
- About the process of notifying QPPV about changes to the PSMF, responsibilities with third parties with whom the company has signed PV/SPA contracts, change control, logbook, archiving, audit trial
- About strategy for maintaining and updating the various sections of the PSMF to ensure that the document reflects the current PV system
- How to develop an SOP for the PSMF maintenance process (including strategies for planning, writing, maintaining and updating the PSMF)
- How to review the key problems and risks in creating, maintaining and updating the PSMF
- How to explain the role of QPPV in the maintenance of the PSMF
- How to predict and eliminate the risk of inspection findings in the field of PSMF
