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

Venue: Ramada Plaza Basel

Location: Basel, Switzerland

Event Date/Time: Apr 04, 2011 End Date/Time: Apr 06, 2011
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This Module provides a comprehensive description on the Common Technical Dossier structure - completely updated to reflect the latest changes in pharmaceutical regulatory affairs. The course is focusing 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 recent ICH-Q guidelines.
The course is for new developments, but is also very much attractive for Generics. In addition, this training course addresses Quality by Design aspects and issues.

Key Topics

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

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