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.

SUBJECT SELECTION:

• 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

STRUCTURE:

• Individual or group instruction
• One-day or multi-day seminars
• Presentations on site