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

 
  January 03, 2011  
     
 
Ramada Plaza Basel, Basel, Switzerland
Apr 4 2011 8:00AM - Apr 6 2011 5:00PM


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

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
 
 
Organized by: DIA Europe
Invited Speakers: See website
 
Deadline for Abstracts: Call contact
 
Registration:
Contact Information:
DIA Europe 
ELISABETHENANLAGE 25, POSTFACH

4002 BASEL 

SWITZERLAND

 

TEL.: +41 61 225 51 51
FAX:  +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG

E-mail: diaeurope@diaeurope.org
 
   
 
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