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.
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Review EU legal requirements for PSMF and GVP Module II requirements
- Content of Core PSMF and Annexes and understanding PSMF modular approach
- Concept of a global PSMF: review on particularities, overlap and discrepancies of local requirements (i.e. within EU, Eurasian and Arab countries)
- Practical approach to design of global PSMF vs local annexes
- Responsibilities and accountabilities for content and maintenance of global PSMF within organization
- Hands on exercise
- Q & A
- Importance of PSMF for the PV audits and PV inspections
- PSMF implementation globally
- Overcoming challenges on preparation and developing effective PSMF maintenance within organization
- Developing sustainable lifecycle quality management system supporting global PSMF
- Overcome common inspection findings and pitfalls relating to PSMF
- Hands on exercise
- Q & A
Natasa Mihajlovic,
Managing Director, NostraPharma Ltd
Natasa Mihajlovic is an experienced European Qualified Person for Pharmacovigilance, certified trainer and certified lead auditor with over 23 years’ experience in the pharmaceutical consultancy and industry coupled with MSc in pharmacovigilance. She has worked at the corporate and affiliate level and has been consultant since 2008. During her consultancy career, Natasa has worked with big pharma as well as, a number of small and medium sized companies with headquarters in the USA, UK, Sweden, France, Spain, Belgium, Italy, Germany, India and Japan. She has been auditing since 2005 and with experience of over 230+ audits and +540 days auditing, has reviewed 90+ PSMFs, performed about 70+ PSMF gap analysis and has conducted a number of PSMF process audits. As a EU QPPV, she has set up first PSMF in August 2012 and since has assisted a number of companies to set up and maintain PSMF. Natasa has taken part in the multiple regulatory pre-inspections and inspections (including EMA, FDA, Swedish, French, German, Croatian, Turkey, Hungarian Regulatory Authority and number of MHRA inspections).
In 2008, Natasa has established NostraPharma Ltd. NostraPharma Ltd is a group of the independent Senior Consultants each with 20+ years’ experience, knowledge, and potential to provide a variety of PV and quality services. NostraPharma Ltd specializes in setting up and improvements of PV quality systems, QPPV office including PSMF maintenance, GVP/GCP remote and process audits, inspection readiness and gap analysis.
Natasa has a passion for training and is a Visiting Lecturer at the University of Hertfordshire, UK.
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