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

Date(s) And Time(s):
Nov 27 2011 7:00AM - Nov 29 2011 3:00PM

Radisson Blu Hotel
Golf Plaza, Yas Island
P.O. Box 93725
Abu Dhabi
United Arab Emirates

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

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

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
- Development Managers and Experts
- QA and New Manufacturing Managers
Level: Beginner to Intermediate

Event Code:

Contact Information:
DIA Europe
4002 BASEL
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52