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:
Please note that we are also running:
This course will be relevant for anyone working in pharmacovigilance requiring a comprehensive overview of the PSMF, including QPPVs and those responsible for safety assessments. It will also be of interest to those who work with pharmacovigilance, eg in regulatory affairs, clinical, sales and marketing, legal, commercial and quality.
09.00 Registration and Coffee
09.30 Meeting begins
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
17.00 Meeting ends
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.