About course
PSMF is a detailed description of the Pharmacovigilance (PV) system used by the marketing authorisation holder (MAH) with respect to one or more authorised medicinal products. The PSMF is a legal requirement – it is required for all medicinal products authorized in the EU, irrespectively of the registration procedure and all MAHs, irrespectively of their organizational structure. The structure of the PSMF is strictly controlled by the guidelines of the GVP: Module II. The PSMF must contain specific sections with details of the pharmacovigilance system. Would you like to know more? If so, please join the course!
By attending this course, you will learn:
- How to understand of key PSMF concepts
- About the key regulations and guidelines for the PSMF
- About the roles and responsibilities of the various entities involved in the management of the PSMF
- Basic theoretical knowledge of PSMF
- About the purpose and scope of the PSMF
- How to apply the concepts, principles, methods and tools in practice, while independently performing tasks related to the management of the PSMF
- About the structure of the PSMF, the PSMF template, the level of detail of the information required by the PSMF, the process of preparing the annexes and the PSMF logbook
- How to prepare individual PSMF sections (EU QPPV, safety data sources, IT and databases, safety processes, audits, company quality system)
- About examples of typical PSMF inspection findings and deficiencies
- About the process of notifying QPPV about changes to the PSMF, responsibilities with third parties with whom the company has signed PV/SPA contracts, change control, logbook, archiving, audit trial
- About strategy for maintaining and updating the various sections of the PSMF to ensure that the document reflects the current PV system
- How to develop an SOP for the PSMF maintenance process (including strategies for planning, writing, maintaining and updating the PSMF)
- How to review the key problems and risks in creating, maintaining and updating the PSMF
- How to explain the role of QPPV in the maintenance of the PSMF
- How to predict and eliminate the risk of inspection findings in the field of PSMF
Competences covered by this course
- Pharmacovigilance System Master File
By attending this course, you will learn
- How to understand of key PSMF concepts
- About the key regulations and guidelines for the PSMF
- About the roles and responsibilities of the various entities involved in the management of the PSMF
- Basic theoretical knowledge of PSMF
- About the purpose and scope of the PSMF
- How to apply the concepts, principles, methods and tools in practice, while independently performing tasks related to the management of the PSMF
- About the structure of the PSMF, the PSMF template, the level of detail of the information required by the PSMF, the process of preparing the annexes and the PSMF logbook
- How to prepare individual PSMF sections (EU QPPV, safety data sources, IT and databases, safety processes, audits, company quality system)
- About examples of typical PSMF inspection findings and deficiencies
- About the process of notifying QPPV about changes to the PSMF, responsibilities with third parties with whom the company has signed PV/SPA contracts, change control, logbook, archiving, audit trial
- About strategy for maintaining and updating the various sections of the PSMF to ensure that the document reflects the current PV system
- How to develop an SOP for the PSMF maintenance process (including strategies for planning, writing, maintaining and updating the PSMF)
- How to review the key problems and risks in creating, maintaining and updating the PSMF
- How to explain the role of QPPV in the maintenance of the PSMF
- How to predict and eliminate the risk of inspection findings in the field of PSMF
Few words from Course SME
Hello! I am Katarzyna, currently serving as a Junior Pharmacovigilance Manager at Teva Pharmaceuticals, and I am eager to welcome you to the AIDIFY platform.
My journey in the field of Pharmacovigilance has been both diverse and enlightening. After kick-starting my career as a Senior Pharmacovigilance and Regulatory Affairs Specialist, I ascended to more focused roles such as Pharmacovigilance and Eudravigilance Expert, and later as a Manager at Rapofarm. These varied experiences have equipped me with a wealth of knowledge and practical insights in the arena of drug safety.
I hold a Master’s degree in Pharmacy from the distinguished Medical University of Warsaw, an academic foundation that has significantly influenced my professional pathway. This solid theoretical groundwork, combined with my industry experience, enables me to provide a comprehensive and applied learning experience.
On this e-learning platform, I am excited to share my insights, tips, and experiences. I am here to help you navigate the intriguing world of Pharmacovigilance and ensure your journey is as enlightening as it is rewarding.
So, come join me, and let’s embark on this enriching learning expedition together. The journey to mastering Pharmacovigilance begins now.
Medical Projects Manager – skilled in leading, motivating, and coordinating teams and projects. Pharmacist. Mother of a 7-year-old girl.
With over 10 years of experience in the pharmacovigilance sector and expertise in medical information. More than three years of experience as a backup EU QPPV at Poland’s largest pharmaceutical company, Zakłady Farmaceutyczne “POLPHARMA” S.A. Contributed to the development and maintenance of a new set of SOPs and PSMF.
Pioneered a new model of pharmacovigilance activities, overseeing the procurement of pharmacovigilance services. Led the project to establish a new global pharmacovigilance structure for the Polpharma Group.
Nearly four years of experience in people management as the coordinator of periodic reporting and risk minimization teams. Managed 4-5 direct reports.
Responsibilities included:
- Aggregate reports
- Risk management (plans, routine and additional risk minimization activities)
- Pharmacovigilance training for company staff (8,000 employees)
- Safety data exchange agreements
- Pharmacovigilance service agreement
- Extended EudraVigilance Medicinal Product Dictionary reporting
- Post-authorization safety studies
- Safety reporting in clinical trials
Skills:
- Lean management
- Negotiation
- Intellectual curiosity
- Enthusiasm
- Persuasion skills
- Organizational skills
- Proficiency in multitasking with keen attention to detail
After-hours interests:
- Literature
- Rock music
- 1960s fashion and design
- Art history
- Camino de Santiago and the Trans-Siberian Railway
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