CTD Dossier Requirements:Focus on EU Module 1 and Quality Module 3

High Quality of a registration dossier facilities the registration procedure - Essential for Generics!

This course provides a comprehensive description of the Common Technical Dossier (CTD) structure - completely updated to reflect the latest changes in pharmaceutical regulatory affairs. The course will focus on the specific regional EU requirements for Module 1 including discussion of the relevant legislation.

The requirements for the Quality documentation (Module 2.3 & 3) will be presented in detail, taking into account the most recent ICH-Q guidelines. The course is for new developments, but is also very much aimed at Generics. In addition, this training course addresses Quality by Design aspects and issues.

Key Topics

• CTD, eCTD
• EU Module 1
  - Cover Letter
  - Application Forms
       - New Applications
       - Variations
  - Product Information
  - Environmental Risk Assessment
  - Information relating to Orphan Market Exclusivity
  - Risk-management System
  - Paediatric Information
• Module 3
  - Pharmaceutical Development and Quality Risk Management
  - Quality of Active Substance including Purity Issues
  - Impurity Testing
  - Stability Testing
  - Setting of Specifications
  - Pharmaceutical Quality System
  - Development and Validation of Analytical Methods