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Stability Testing for Drug Substances and Drug Products - Barcelona, Spain

: 29 Nov 2018 - 30 Nov 2018

: Barcelona, Spain

Sector: Pharmaceutical

Type: Training


This event is intended to provide information on different aspects of stability testing. The conference will be opened by an overview of stability testing with a special focus on important changes in current revisions of ICH Guidelines. In the subsequent presentations, practical aspects of stability testing for drug substances and throughout drug development are discussed.

The second day commences with a lecture on stability testing for Drug Products and a risk based approach for stability testing covering different climatic zones. In the following talks special consideration is given to the various aspects of post-marketing stability testing procedures. The specific challenges of data evaluation and the structure of the Common Technical Document (CTD) will then be addressed.

Programme

Current ICH and CHMP Guidelines for Stability Testing
Stability Testing throughout Drug Development
Stability Testing for Drug Substances
Stability Testing for Drug Products
Submitting Stability Data – The CTD Structure
Evaluation of Stability Results – Statistical Considerations
Post-marketing Stability Testing
 

Find out more:
Venue

Barcelona
Spain


Organizer

European Compliance Academy
Phone: +[49] 6221-84 44 15
Email: info@gmp-compliance.org
Visit: http://www.gmp-compliance.com


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