- 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.
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.
Attend one of our free pre-meetings to familiarise yourself with the Learning Space and the various ways in which you can interact during the event
With our modular qualification course, you can expand your competencies in drug regulatory affairs in a targeted and practice-oriented manner. You design your learning pathway individually and set professional focus areas in line with your occupational requirements. Including an overall certificate and up to 30% price advantage compared with individual bookings.
e-Learning in 5 modules: concept, data requirements and the AMNOG process up to the price negotiation
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
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 e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe (MRP, DCP, CP) . It will also introduce you to post-authorisation duties (renewal, variation...).
Three e-Learning programmes in one bundle: Get a solid foundation in EU marketing authorisation procedures, the EU variation system and the Common Technical Document (eCTD). Your fast track into EU Regulatory Affairs - at a special bundle price.
