Title:
CTD Dossier Requirements: Focus on EU Module 1 and Quality Module 3
Date(s) And Time(s):
Mar 24 2010 8:00AM - Mar 25 2010 5:30PM
Location:
Taj Banjara
Road No. 1
Banjara Hills
Hyderabad 500034
Andhra Pradesh
India
Interest Area(s):
Regulatory Affairs,Clinical Research,Public Policy/Law/Corp. Compliance,Research & Development,Project Management
Overview:
Techniques to Ensure High Quality Registration Dossiers Facilitate the Registration Procedure 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.
Featured Topics
CTD, eCTD
EU Module 1
• Cover Letter
• Application Forms
• 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
Learning Objectives:
At the conclusion of this course, participants should be able to:
• Identify the recent requirements for developing drug substance and drug products and setting up a
registration dossier — especially for generics
• Define the requirements for developing a product and discuss how to prepare the regional EU
Module 1 and the Quality documentation
• Discuss the legal background of the dossier requirements and identify the relevant guidelines
• Demonstrate optimal presentation of information and justifications
Target Audience:
Governmental institutions
• Pharmaceutical industry professionals
• Development managers and experts
• QA and new manufacturing managers
Event Code:
10651
Contact Information:
Fahd Khan, Manager Marketing & Program Development, DIA (India) Private Limited;
Cell: +91-9223267327, Fax: +91-22-28594762, Email: Fahd.Khan@diahome.org
Vinisha Bhavsar, Program & Operations Assistant, DIA (India) Private Limited;
Cell: +91-9004682564; Fax: +91-22-2859-4762; Email: dia.diaindia@gmail.com
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