A Practical Guide to Producing and Maintaining the PSMF
All EU regulatory pharmacovigilance Inspections start with the assessment of the PSMF. The PSMF provides the regulators with not only a detailed assessment of the system but the outputs from that system contained in the Annexes provide an understanding of a company’s compliance. This course will provide a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the 2017 update.
Topics to be covered include:
- Production, maintaining and updating the PSMF
- Maintaining the Annexes associated with the PSMF
- Control of the PSMF including the EU QP PV and the XEVMPD
- The PSMF and major changes
- The PSMF audits and inspections