About course
Gain a comprehensive understanding of the pivotal role of the Qualified Person Responsible for Pharmacovigilance (QPPV) with our engaging course, “Introduction to the Role of QPPV.” Whether you’re new to pharmacovigilance or seeking to deepen your expertise, this course offers essential insights into the legal framework, regulatory requirements, and key responsibilities associated with the QPPV role.
As a central figure in the pharmacovigilance system, the QPPV plays a crucial role in ensuring the safety and effectiveness of medicinal products. Through this course, you’ll explore:
- Basic abbreviations, terminology, and key concepts related to the QPPV role.
- Regulatory requirements and guidelines governing pharmacovigilance in the EU.
- Roles and responsibilities of the EU QPPV, including oversight of the pharmacovigilance system and specific medicinal products.
- Preparation strategies for inspections and audits as a QPPV, along with an overview of PV inspection types.
- Supervision of the pharmacovigilance system in both small pharmaceutical companies and global corporations.
- Configuration of a complete PV system, including task delegation processes, PSMF oversight, and quality management.
- Management of service providers, business partners, and product safety issues, including signal and risk management.
Course Highlights:
- Expertly crafted presentation to provide in-depth insights into the role of the QPPV.
- Obtain a recognized certificate upon successfully passing the course test.
- Collaborate and discuss course content with fellow learners on the AIDIFY platform, enhancing your understanding through interaction.
Would you like to know more? Join the course!
Competences covered by this course
- Qualified Person Responsible for Pharmacovigilance
By attending this course, you will learn
- Basic abbreviations related to QPPV role
- Basic terminology and can explain key concepts related to QPPV; knows qualifications required for QPPV role
- Regulatory requirements and guidelines related to QPPV; knows EU pharmacovigilance regulations and guidelines in force
- Roles and responsibilities of EU QPPV, responsibilities regarding PV system and certain medicinal product
- How to prepare for inspection/audit as a QPPV; understands PV inspection types
- How to supervise the PV system; understands PV system in global corporation (safety database; standard operating procedures set; network of local and regional experts)
- The role of QPPV in a small pharmaceutical company and a global corporation; can draw possible scenario of PV system
- The central role of QPPV in pharmacovigilance practice (responsibilities of QPPV; EU QPPV)
- Configuration of complete PV system: provide PV task delegation process and QPPV back-up; understand need for back-up procedure creation
- The process of delegating tasks, communication and escalation; understands subcontracting tasks to another organization
- The PSMF oversight process; understands what kind of document is PV System Summary
- The quality management process; understands responsibilities of managerial staff regarding quality system
- The process of managing service providers and business partners
- The process of product safety management and signal management; understands goals of signal and risk management; understands emerging safety issues management
- Development an action plan to prepare QPPV for audit / inspection
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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