- Modular training programme consisting of three selected seminars and one elective module for Heads of Pharmacovigilance - Learn the responsibilities and legal aspects of managing a PV system and its staff, and select an elective module according to your individual interests.
- Modular training programme consisting of three selected seminars for Qualified Persons for Pharmacovigilance - Gain insight into the legal framework and core responsibilities of the Qualified Person for Pharmacovigilance (QPPV), then deepen your professional and practical knowledge to perform your role more effectively.
This online-seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide. Register today!
Outsourcing of areas, tasks, or positions in pharmacovigilance is often standard practice. In this training course, you will not only gain the necessary knowledge to work with service providers but also learn in practice how to monitor them effectively and manage a robust quality system.
This online two-day course equips new, aspiring, and practising QPPVs with a clear understanding of their role under EU pharmacovigilance legislation, focusing on key responsibilities, strategic planning, and effective oversight. Learn what it takes to perform the role in practice and ensure ongoing compliance.
Regulatory expectations regarding risk management for pharmaceuticals in (emerging) markets often contend with the stringent standards set by the EU/ICH regions. Join us in five consecutive webcasts to gain insights into local pharmacovigilance systems in different countries and regions, and learn how to integrate them into your global PV system while maintaining a clear overview!
Join our interactive course to explore how AI is transforming pharmacovigilance. Take part in discussions, hands-on workshops, and case studies while diving into AI technologies, regulations, and their applications in drug safety. Register now to participate, share insights, and collaborate with peers!
This online training offers comprehensive insights into Regulatory Affairs, CMC, and GMP requirements, with a focus on the latest updates and developments in EAEU countries.
In this interactive two-day seminar, you will explore signal management best practices using PRAC case studies and learn how to effectively leverage digital tools such as EudraVigilance, programmable data analysis and AI. Complementary perspectives from both the marketing authorisation holder and the former authority provide valuable insights for your day-to-day work.
During our online training "Toxicology and beyond: Safety assessment in drug development" you will build a solid toxicological know-how basis and will be informed about the inclusion of toxicological data in the marketing authorisation dossier. Take the chance and participate in our interactive online training.
Are you involved in the implementation and ongoing adaptation of the PV system? In this online course you will learn how to use the right Key Performance Indicators (KPIs) for your PV system to strengthen compliance and inspection readiness. Reserve your seat now and be part of this insightful session!
