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Pharmaceutical

A Practical Guide to Producing and Maintaining the PSMF

30 Jan 2018

GBP EUR USD
Standard 699 979 1090
Early 599 839 934
Excluding VAT @ 20.00%

Book by 15 Dec to get the early booking price shown above.

Venue: Rembrandt Hotel, London

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5 Jul 2018

GBP EUR USD
Standard 699 979 1090
Excluding VAT @ 20.00%

Venue not yet confirmed

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Bespoke training

We can customise this course to meet the requirements of your organisation.

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Course Overview

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 aspet for maintaining the Company compliance and these are reviewed in Regulatory Inspections. Can you afford not to get it right?

Topics to be covered Include:-

  • 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

Why you should attend

EU Regulatory Authorities are visiting all licence holders to perform inspections on a Company’s compliance to Pharmacovigilance and the visits start with the assessment of the PSMF. This document provides the Regulators with not only the detailed assessment of the system but also the outputs from that system contained in the Annexes to gain an understanding of the Company compliance. The new Pharmacovigilance Legislation of 2012 now requires companies to provide a PSMF and that this document should be ‘Inspection ready’. If this is not done correctly this can result in critical findings for the Company that could set back further product launches or even sanctions against the Companys existing products. Maintenance of the PSMF also is an important aspect for maintaining the Company compliance and these are reviewed in Regulatory Inspections. Can you afford not to get this right?

Who should attend

This course will be relevant for anyone requiring a comprehensive overview of the Pharmacovigilance function and duties. It may be of particular interest to 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 & Marketing, Legal, Commercial and Quality and IT that must sign off such documents.

Programme

An Introduction to PSMFs

  • The DDPS
  • Converting the DDPS to the PSMF
  • Requirements for the PSMF
  • Declarations for the PSMF

The Content of the PSMF

  • The PSMF template
  • The detail in the PSMF
  • Preparation of the Annexes
  • The PSMF Log Book

The Sections of the PSMF

  • Section on the EU QP PV
  • Sources of Safety Data
  • IT & Databases
  • Regulatory timeline compliance
  • The PSMF processes
  • Testing of Quality in the PSMF
  • The Company Quality System

The Annexe requirements for the PSMF

  • The Company Product List
  • The EU QP PV list of delegated tasks
  • The list of SOPs and procedures
  • List of delegated activities to Third party partners
  • A List Of Completed Audits And Schedules
  • A List Of Performance Indicators For The PSMF Section
  • The roles and responsibilities of the EU QP PV
  • Master File number and version changes

Presenter

Graeme Ladds

Graeme Ladds, Director of PharSafer, has over 26 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.

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Previous customers include...

  • Alfa Wassermann S.p.A.
  • A Nelson & Co Ltd
  • Alkaloid AD Skopje
  • Allergan
  • Athlone Laboratories
  • Besins Healthcare
  • Boots UK Ltd
  • Chiesi Farmaceutici SPA
  • Conforma NV
  • DBV Technologies
  • Del Corno & Associati s.a.s
  • Eisai Europe Limited
  • Ewopharma International s.r.o
  • FAES FARMA SA
  • Gilead Sciences International Ltd
  • GRUPO FERRER INTERNACIONAL SA
  • Iggea Ltd
  • JensonR+ Ltd
  • Mundipharma Research GmbH & Co Kg
  • Orion Clinical Services Ltd
  • Pharmacovigilance Matters Limited
  • Proge Medica SRL
  • Pure Drug Safety Ltd
  • Real Regulatory Ltd
  • Recordati S.p.A
  • Unimedic Pharma AB
  • Yes Pharma Services GmbH
  • ZAMBON SPA