- 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.
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.
Are you working in the QPPV Office or are you a Local Safety Officer? This focused online course supports your daily responsibilities and strengthens collaboration with national PV teams across the company. Using inspection readiness as a central theme, the training shows how global and local PV functions work together effectively. Register now!
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.
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.
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Including an update on the new (Draft) ICH M4Q(R2) and the Draft of the Revision of the Classification Guideline. Take the chance to participate in our virtual seminar and get qualified.
The compact course with a content focus on the development, production and analytics of biotech drugs. Secure your place and qualify now! All three course days can be booked individually (single day = 1.290€ plus VAT) - for booking, please contact us!
This online webcast series provides a concise update on the EU Pharmaceutical Package. Across five two-hour modules, you learn about key regulatory changes, revised authorisation and protection rules, new obligations for managing shortages, and developments in environmental risk assessment. Gain practical guidance to adapt internal processes and responsibilities to the upcoming framework.
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!
