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

Location:
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

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

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:
11533

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

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