All EU regulatory pharmacovigilance Inspections start with the assessment of the 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 2017 update.
Topics to be covered include:
Please note that we are also running:
This meeting runs back-to-back with Writing Risk Management Plans (RMPs) on 4 July 2018 and also Risk Evaluation and Mitigation Strategies (REMS) on 6 July 2018. There is a further £100/€140 discount off each course when booked together.
To find out more please call Customer Services on +44 (0)20 7749 4730 or e-mail email@example.com
This course will be relevant for anyone requiring a comprehensive overview of the pharmacovigilance function and duties, particularly those who are responsible in pharmacovigilance for any safety assessments and writing such plans including any EU QP PVs who approve such documents. Those who work with pharmacovigilance, e.g. regulatory affairs, clinical, sales and marketing, legal, commercial and quality must sign off such documents.
The content of the PSMF
The sections of the PSMF
The Annexe requirements for the PSMF
The PSMF and inspections
Requests for the PSMF
The PSMF and quality
Log books and audit trails
The PSMF post inspection
Graeme Ladds (29 Jan 2019)
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.