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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Description

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

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


Event Code:
11534

Venue