A Practical Guide to Producing and Maintaining the PSMF

The pharmacovigilance system master file (PSMF) is a legal requirement for any medicinal product authorised in the European Union. The PSMF provides the regulators with a detailed description and assessment of the entire pharmacovigilance system and the outputs contained in the annexes provide an understanding of a company’s compliance. This course will provide a practical guide to planning, writing, maintaining and updating the PSMF to ensure compliance. The programme will cover the importance of the PSMF in regulatory inspections, including common PSMF inspection findings. You will discuss the processes and systems required to manage the PSMF as well as the latest advice on the impact of Brexit.

Benefits of attending:

• Understand the regulatory requirements for the PSMF
• Gain an overview of the key issues in producing, maintaining and updating the PSMF
• Discuss the PSMF as a QMS document
• Learn about the roles of the QPPV and the PSMF
• Review common inspection findings and deficiencies related to the PSMF