PV System Master File Training Course
This is a 3-day training programme which spans over three half-days.
Attending the full 3 days is mandatory.
17 – 19 May 2022
12.00 pm – 15.00 pm (London, UK)
What you will learn:
- 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
Programme
Agenda
Day 1 – Tuesday 17th May
12.00pm – 12.10pm Introductions
12.10pm – 12.40pm Introduction and background to the PSMF
- The DDPS and the PSMF
- Objectives of the PSMF
12.40pm – 12.50pm Q & A
12.50pm – 13.20pm Introduction and background to the PSMF (cont)
- Registration of the PSMF
- Regulatory requirements and accessibility of the PSMF
- Responsibilities of the marketing authorisation holder, updates and the EU QPPV
13.20pm – 13.30pm Q & A
13.30pm – 13.40pm Refreshment Break
13.40pm – 14.10pm The content of the PSMF
- The PSMF template
- The level of detail required by the PSMF
14.10pm – 14.20pm Q & A
14.20pm - 14.50pm The content of the PSMF (cont)
- Preparation of the annexes
- The PSMF logbook
14.50pm – 15.00pm Q & A
Day 2 – Wednesday 18th May
12.00pm – 12.10pm Recap
12.10pm – 12.40pm The sections of the PSMF
- The EU QPPV
- Sources of safety data
- IT and databases
12.40pm – 12.50pm Q & A
12.50pm – 13.20pm The sections of the PSMF (cont)
- Regulatory timeline compliance
- The PSMF processes
- The PSMF and audits
- The company quality system and the PSMF
13.20pm – 13.30pm Q & A
13.30pm – 13.40pm Refreshment Break
13.40pm – 14.10pm 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
14.10pm – 14.20pm Q & A
14.20pm - 14.50pm The annex requirements for the PSMF (cont)
- 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)
14.50pm – 15.00pm Q & A
Day 3 – Thursday 19th May
12.00pm – 12.10pm Recap
12.10pm – 12.40pm The PSMF and inspections
- The PSMF and inspection findings
- Regulatory authority requests to view the PSMF
12.40pm – 12.50pm Q & A
12.50pm – 13.20pm Responsibility
- Transfer of responsibility for a pharmacovigilance system to the QPPV
- Notifying the QPPV of changes to the PSMF
13.20pm – 13.30pm Q & A
13.30pm – 13.40pm Refreshment Break
13.40pm – 14.10pm Archiving
- PSMF responsibilities with shared marketing authorisation holders
- Change control, logbook, versions, and archiving
14.10pm – 14.20pm Q & A
14.20pm - 14.50pm Audit Trails
- Audit trails and the PSMF
- The PSMF post-inspection
14.50pm – 15.00pm Q & A
