A lot of departments/employees of different organisations are in contact with Regulatory Affairs of the pharmaceutical industry. We offer you seminar designed for NON-RA-PROFESSIONALS who work in close contact with Regulatory Affairs departments.
- Community Marketing Authorisations
- Marketing authorisation procedures
- Application types
- Presentation and content of the Registration dossier Module 1-5
- NPD versus maintenance/lifecycle management
- Maintenance: variation notifications/renewal procedures etc.
- Module 1: SmPC/labelling/PIL/Mock up’s
- The medicinal product dossier – structure and format (NTA, CTD)
- Electronic submissions (NeeS/eCTD) versus paper submissions
- Individual or group instruction
- One-day or multi-day seminars
- Presentations on site