- Combination of three compulsory seminars plus one elective module for (future) Heads of the Pharmacovigilance Department - Learn the responsibilities and legal aspects of managing a PV system and its staff, and select an elective module according to your individual interests.
- Combination of three selected seminars - With this qualification course, you will first gain insight into the legal aspects and general responsibilities of the Qualified Person for Pharmacovigilance (QPPV). You will then deepen your professional and practical knowledge to perform your role more effectively.
With this qualification course, you can continue your education in a structured manner in all CMC topics, with a technical focus on development methods, manufacturing processes, CMC documents, change management, and much more.
Stay informed with updates from our global and local experts, who will provide the latest regulatory and legislative insights every two months. In 2026, topics will include CMC documentation, regulatory intelligence, regulatory pathways in Africa, enrichment of PMS product data, global regulatory reliance models and ePI.
This two-day course equips new or in future QPPVs with the fundamentals of EU pharmacovigilance legislation, QPPV responsibilities, and strategic planning. Learn what it takes to fulfil the role, ensure compliance, and build your roadmap to QPPV readiness. Ideal for aspiring QPPVs or those preparing future candidates. Secure your place today!
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!
Global variations and lifecycle management - covering key regions: USA, Asia (China, Japan, South Korea), LATAM (Central America, Brazil), and Gulf Cooperation Council (GCC). Take this opportunity to discuss your specific daily business challenges with our experts and network with peers to see how others approach similar issues!
Do you already have a good understanding of PSUR and RMP including risk minimisation measures and would like to deepen, broaden and update your knowledge? In this course, you will enhance your practical skills in preparing, assessing, and managing RMPs and PSURs, and learn about the latest requirements of GVP Module XVI (Rev. 3) and the new Implementing Regulation (EU) 2025/1466.
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.
Learn how to prepare your pharmacovigilance system in Germany, Europe and worldwide for an upcoming inspection in this one-day online course. Gain a comprehensive understanding of the EMA's Good Pharmacovigilance Practice (GVP/GPvP) modules, strategic and remote planning and preparation, and differences in GVP inspections around the world.
You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with practical tips and tricks and share their experiences with you. After attending this virtual seminar you will be able to present data clearly and in compliance with the regulations.
