Qualification Course: Qualified Person for Pharmacovigilance (QPPV)

The qualification programme provides you with sound, practice-oriented knowledge for your responsibilities as QPPV or national Safety Officer. The three consecutive seminars take you from essential regulatory knowledge to strategic topics for experienced pharmacovigilance professionals.

The EU Qualified Person for Pharmacovigilance (EU QPPV)
Legal foundations, core responsibilities, and practical application

2 days | Online Seminar | 2 fixed dates per year

This intensive course provides a comprehensive introduction to the regulatory, organisational and practical requirements for EU QPPVs. You will gain a clear understanding of your role and responsibilities and learn how to manage your tasks confidently and systematically in day-to-day business.

Topics:

• Legal framework, liability, and legal protection
• Regulatory requirements for day-to-day practice
• Maintaining oversight of your pharmacovigilance system
• Specific tasks, responsibilities, and possible delegations
• Ensuring compliance

Advanced Class: The Global Network of Local and Regional QPPVs
Global Collaboration and Inspection Readiness

1 day | Online Seminar | 1 fixed date per year

This Advanced Class is designed for participants who wish to deepen their knowledge and gain a better understanding of how the global pharmacovigilance roles interact. The focus is on international collaboration, preparation for inspections and audits, and the confident handling of regulatory and organisational requirements.

Topics:

• Responsibilities and collaboration between QPPVs and National Safety Officers
• Overview: Country-specific regulatory requirements
• SOP and PSMF management
• Local and global inspections and audits
• Best practices in risk and crisis management

Master Class: Local QPPV, EU QPPV, and Head of PV
The advanced seminar for experienced pharmacovigilance professionals

1 day | Online Seminar | 1 fixed date per year

This Master Class addresses key strategic and operational questions that experienced pharmacovigilance professionals face in their daily work. You will deepen your knowledge of PV SOPs, the PSMF, complaints, recalls and CAPA, and receive practical input for effective stakeholder and deviation management.

Topics:

• PV SOPs: Which processes require them, and when are they useful?
• PSMF: One document for clarity
• Handling complaints and product recalls
• Stakeholder management
• Deviation management and CAPA

You will take part in three live training sessions (modules) within 24 months. These take place on fixed dates. We plan our events approximately six months in advance. You can select any dates that have already been published when booking. If you would prefer to attend a later seminar date, please select the option "Please inform me about upcoming dates by email". The three compulsory modules provide you with a comprehensive overview of the responsibilities and essential tasks of a Qualified Person for Pharmacovigilance.

You may begin the qualification programme with any seminar. Please note, that only the module "Qualified Person for Pharmacovigilance (EU QPPV)" covers the regulatory foundations of the role. The other two modules focus on specific tasks and practical duties associated with the position. For participants with little prior familiarity with these responsibilities, we recommend starting with this module.

Our compulsory modules are offered at least once a year. If you are unable to attend on a specific date, or if your preferred seminar is not yet available online, this is not a problem. Simply book the qualification course, and we will arrange the seminar dates with you individually.
If you have any questions or would like personal support in selecting or booking your modules, please feel free to contact me directly at n.wolff@forum-institut.de or by telephone at 06221 500-696.

• Your employer invests in high-quality and well-prepared knowledge transfer, ensuring a solid foundation of expertise within the company.
• You are up to date and contribute current know-how to the organisation.
• Benefit from the carefully selected seminar package and approve four training sessions in one process.
• Your employer saves up to 25% compared with individual seminar bookings.