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
Certification:
- CPD: 6 hours for your records
- Certificate of completion
Course Content
Introduction, welcome and objectives
Introduction and background to the PSMF
- The DDPS and the PSMF
- Objectives of the PSMF
- Registration of the PSMF
- Regulatory requirements and accessibility of the PSMF
- Responsibilities of the marketing authorisation holder, updates and the EU QPPV
The content of the PSMF
- The PSMF template
- The level of detail required by the PSMF
- Preparation of the annexes
- The PSMF log book
The sections of the PSMF
- The EU QPPV
- Sources of safety data
- IT and databases
- Regulatory timeline compliance
- The PSMF processes
- The PSMF and audits
- The company quality system and the PSMF
The annex requirements for the PSMF
- The company product list
- The EU QPPV list of delegated tasks
- The list of SOPs and procedures
- List of delegated activities to third-party partners
- A list of completed audits and schedules
- A list of performance indicators for the PSMF section
- The roles and responsibilities of the EU QPPV
- Master file number and version changes (audit trail)
The PSMF and inspections
- The PSMF and inspection findings
- Regulatory authority requests to view the PSMF
- Transfer of responsibility for a pharmacovigilance system to the QPPV
- Notifying the QPPV of changes to the PSMF
- PSMF responsibilities with shared marketing authorisation holders
- Change control, logbook, versions and archiving
- Audit trails and the PSMF
- The PSMF post-inspection
Final discussion session
