A Practical Guide to Producing and Maintaining the PSMF
All EU regulatory pharmacovigilance inspections start with the assessment of the pharmacovigilance system master file (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 latest updates.
By attending this course you will:
- Understand the regulatory requirements for the PSMF
- Gain an overview of the key issues in producing, maintaining and updating the PSMF
- Learn about the roles of the QPPV and the PSMF
- Discuss the PSMF and regulatory inspections