Get Information To Be Contained In The Psmf/ Pssf

Filling out the Information To Be Contained In The PSMF/ PSSF is a crucial step in pharmacovigilance documentation. This guide will provide you with clear, step-by-step instructions to help you complete this essential form online.

Follow the steps to effectively fill out the PSMF/ PSSF online.

1. To begin, press the ‘Get Form’ button to access the document. This will allow you to open the form in your preferred digital editor.
2. Complete the cover page by entering the unique number for the revision, the name of the marketing authorization holder (MAH), the qualified person responsible for pharmacovigilance (QPPV), any other concerned MAHs, and the date of preparation or last update.
3. Provide details about the QPPV, including a description of their responsibilities, a summary curriculum vitae, contact information, back-up arrangements, and relevant practical experience or training.
4. Outline the organizational structure associated with the MAH, detailing the roles of the QPPV within the local office. Include sites where pharmacovigilance functions are conducted and delegated activities related to service providers.
5. Document the sources of safety data by describing the main units involved in safety data collection, listing all responsible parties, and including medical information sites. Ensure that the table includes product names, countries, nature of activities, and contact points.
6. Summarize the computerized systems and databases utilized for managing safety information. Provide details on their location, functionality, and operational responsibilities.
7. Detail the pharmacovigilance processes, including data handling and record-keeping practices. Ensure you include validation status, change control information, and a clear explanation of continuous monitoring of risks associated with products.
8. Describe the quality system, involving procedural documents and organizational structure. Include information on training provided for staff involved in pharmacovigilance, as well as details of auditing practices and planned schedules.
9. Complete the annexes that accompany the PSMF/ PSSF, attaching relevant documents such as the curriculum vitae of the QPPV, lists of contracts, and sources of safety data, among others.
10. After all sections are filled out thoroughly, ensure to save your changes. You may choose to download, print, or share the completed form as needed.

Start filling out your PSMF/ PSSF online today to ensure compliance and effective pharmacovigilance management.