A Practical Guide to Producing and Maintaining the Pharmacovigilance System Master File (PSMF) (Jul 05, 2018)
In-Person Event
Jul 05, 2018
London, England, GBSpeakers
OVERVIEW
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 Jul 05, 2018 at The Cavendish Hotel, London, England, United Kingdom.
The target audience for this medical event is anyone requiring a comprehensive overview of the Pharmacovigilance function and duties. It may be of particular interest to those who are responsible for 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 & Marketing, Legal, Commercial and Quality and IT that must sign off such documents.
Course Description:
The new pharmacovigilance legislation of 2012 now requires companies to provide a PSMF and that this document should be ‘Inspections ready’. If this is not done correctly this can result in critical findings for the Company that could set back further product launches or event sanctions against the Company existing products. Maintenance of the PSMF also is an important aspect of maintaining the Company compliance and these are reviewed in Regulatory Inspections.
The pharmacovigilance legislation of 2012 requires companies to provide Risk Management Plans (RMPs) and assessments for all new products, whether generic products or new chemical entities.
Topics:
• The Changeover from the DDPS to the PSMF
• Production of the PSMF
• Maintaining and Updating the PSMF
• Maintaining the Annexes associated with the PSMF
• Control of the PSMF
Tickets:
EUR 1,174.80
USD 1,308.00
Additional details will be posted as soon as they are available.
The target audience for this medical event is anyone requiring a comprehensive overview of the Pharmacovigilance function and duties. It may be of particular interest to those who are responsible for 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 & Marketing, Legal, Commercial and Quality and IT that must sign off such documents.
Course Description:
The new pharmacovigilance legislation of 2012 now requires companies to provide a PSMF and that this document should be ‘Inspections ready’. If this is not done correctly this can result in critical findings for the Company that could set back further product launches or event sanctions against the Company existing products. Maintenance of the PSMF also is an important aspect of maintaining the Company compliance and these are reviewed in Regulatory Inspections.
The pharmacovigilance legislation of 2012 requires companies to provide Risk Management Plans (RMPs) and assessments for all new products, whether generic products or new chemical entities.
Topics:
• The Changeover from the DDPS to the PSMF
• Production of the PSMF
• Maintaining and Updating the PSMF
• Maintaining the Annexes associated with the PSMF
• Control of the PSMF
Tickets:
EUR 1,174.80
USD 1,308.00
Additional details will be posted as soon as they are available.
KEY DATES
05 Jul, 2018
Event Start Date
05 Jul, 2018
Event End Date
SPECIALITIES
Pharmacy and MedicineSUGGESTED HOTELS
CONFERENCE VENUE
The Cavendish HotelRELATED CONFERENCES & LIVE WEBINARS
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