- 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.
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.
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 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...).
Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.
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.
