Conference Description:

The pharmacovigilance system master file (PSMF) is up-to-date comprehensive and dynamic document providing company employees (including regional or local Qualified Person for Pharmacovigilance, PV auditors etc) and the regulators with a detailed description of the entire PV system.

The PSMF has been a mandatory legal requirement for any medicinal product authorized in the European Union (EU) since 2012. However, in the most recent years, complexity and lack of harmonization has increased by some European (EU) and non-EU regulators requiring a local PSMF, additional PV System Annex/ Supplement/ Sub-File or completely separate PSMF specific to a region. Understanding global legal requirements in regard to PSMF, importance of PSMF within organization and common inspection findings and pitfalls relating to PSMF, can assist companies to develop sustainable quality management system for PSMF maintenance.

In this two day workshop, we will review the global regulatory requirements (predominantly European, Eurasian and Arab League) regarding PSMF. The course will focus on:

Practical approach to design, planning, creating, implementing and maintaining global PSMF to ensure company compliance
Responsibilities and accountabilities for content and maintenance of global PSMF within organization
Importance of PSMF for the PV audits, PV inspections, common inspection findings and pitfalls relating to PSMF
Developing sustainable lifecycle quality management system supporting global PSMF
Understanding how to meet regional/local peculiarities in regard to PSMF (i.e. within EU, Eurasian and Arab countries) and discuss the latest impact of Brexit.
Learning Objectives:
Upon completing of this course, participants should be able to:

Develop sound understanding of global legal requirements and health authority expectations for global PSMF and current interpretation
Gain understanding of importance of PSMF within organisation and externally
Design and structure a PSMF
Develop processes supporting PSMF maintenance
Improve existing processes supporting PSMF maintenance.
Areas Covered:
PSMF content
Legal requirements regarding PSMF
Quality management system supporting PSMF maintenance
Practical approach to design and implementation of PSMF
Who will Benefit:
This course is designed for people who are tasked with contributing, developing, maintaining, updating and/or reviewing the PSMF and those working in PV who require comprehensive overview of PSFM. It is also beneficial for the personnel who are responsible for the quality oversight and auditing of PV system.

The following personnel will benefit from the course:

Relevant Pharmacovigilance Personnel
PV Quality Assurance Personnel
PV Compliance Professionals
PV Auditors who require 360o understanding of PSMF and PSMF maintenance or those who have attended Compliance Online seminar “The Risk-Based Approach to Pharmacovigilance Audits - A Practical Approach to Design and Implementation”
Regulatory Affairs
Clinical operations
Commercial, marketing and sales
Legal
PV Service Providers who are providing PV services outside USA.