Date(s) And Time(s):
Apr 26 2012 8:00AM - Apr 27 2012 5:00PM
Kazlicesme Mah. Kennedy Cad. No: 56
High Quality of a registration dossier facilities the registration procedure - Essential for Generics!
This course provides a comprehensive description of the Common Technical Dossier (CTD) structure - completely updated to reflect the latest changes in pharmaceutical regulatory affairs. The course will focus 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 most recent ICH-Q guidelines. The course is for new developments, but is also very much aimed at Generics. In addition, this training course addresses Quality by Design aspects and issues.
EU Module 1
- Cover Letter
- Application Forms
- New Applications
- Product Information
- Environmental Risk Assessment
- Information relating to Orphan Market Exclusivity
- Risk-management System
- Paediatric Information
- 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
At the conclusion of this course, participants should be able to:
Understand 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
- Development managers and experts
- Quality Assurance (QA) and new manufacturing managers
Level: Beginner to Intermediate
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.
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.
KUECHENGASSE 16, POSTFACH
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52