Course overview
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. We will discuss the processes and systems required to manage the PSMF as well as the latest advice on the impact of Brexit.
The course will also cover the role of the EU QP PV and Quality Assurance (QA) in the evolution of the PSMF and the internal audit aspects that ensure it is running efficiently and compliantly.
CPD Hours: 6
Course Content
- Day 1
- Introduction and background to the PSMF
- The content of the PSMF
- The sections of the PSMF
- The annex requirements for the PSMF
- The PSMF and inspections
- Final discussion session
Speakers
Graeme Ladds
Graeme Ladds, Director of PharSafer, has over 30 years’ experience in the pharmaceutical industry. He began his career in 1989 at Ashbourne Pharmaceuticals as Head of Drug Safety & Medical Information, before going on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
He later founded his consultancy and specialist CRO, PharSafer Associates Ltd, where he has supported companies in establishing pharmacovigilance systems, conducting audits across Europe and the USA, developing SOPs, acting as a QP, and supporting regulatory inspections.
Since 1994, Graeme has also been involved in the monitoring of medical devices, including drug-device combinations, structural devices and electrical medical devices. His experience spans clinical trials and global device vigilance, alongside pharmacovigilance activities across both clinical development and post-marketing phases.
