Title:
Training course on CTD Dossier Requirements: Focus on EU Module 1 and Quality Module 3
Date(s) And Time(s):
Apr 26 2010 8:00AM - Apr 28 2010 5:00PM
Location:
Hotel Austria Trend Savoyen
Rennweg 16
1030 Vienna
Austria
Interest Area(s):
CMC,Pharmacology,Quality Assurance/Quality Control
Overview:
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
CANCELLATION POLICY
Cancellations must be made in writing and be received at the DIA Europe office five working days prior to the course start date.
Cancellations are subject to an administrative fee:
Full Meeting Cancellation:
Industry (Member/Non-member) = € 200.00
Government/Academia/Non-profit (Member/Non-member) = € 100.00
Registrants who do not cancel five working days prior to the course start date and do not attend, will be responsible for the full registration fee. DIA Europe reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA Europe is not responsible for airfare, hotel or other costs incurred by registrants. Registrants are responsible for cancelling their own hotel and travel reservations.
Transfer Policy
You may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute registrants will be responsible for the non-member fee, if applicable. Please notify the DIA Europe office of any such substitutions as soon as possible.
Event Code:
10529
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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