A Practical Guide to Producing and Maintaining the PSMF (London, United Kingdom - January 30, 2018) - Research and Markets

DUBLIN--()--The "A Practical Guide to Producing and Maintaining the PSMF" conference has been added to Research and Markets' offering.

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 Company's 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?

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

Agenda:

09.00 Registration and Coffee

09.30 Meeting

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

17.00 Close of Meeting

For more information about this conference visit https://www.researchandmarkets.com/research/t844kh/a_practical_guide

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Drug Discovery

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Drug Discovery