A Practical Guide to Producing and Maintaining the Pharmacovigilance System Master File (PSMF) - (Jan 29, 2019)

A Practical Guide to Producing and Maintaining the Pharmacovigilance System Master File (PSMF) is organized by Management Forum (Mf) Ltd and will be held on Jan 29, 2019 at The Cavendish London, London, England, United Kingdom.

The target audience for this medical event is 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.

Conference Description:
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.

Conference Topics:
• Production, maintaining and updating the PSMF
• Maintaining the Annexes associated with the PSMF
• Control of the PSMF including the EU QP PV and the XEVMPD
• The PSMF and major changes
• The PSMF audits and inspections

Prices:
• Conference Early Fee : EUR 1006.80 - Until 20 Dec 2018
• Conference Fee : EUR 1174.80 
• Conference Fee : USD 934 - Until 20 Dec 2018
•  Conference Fee : USD 1090

Additional details will be posted as soon as they are available.