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8-Hoerner

8-Hoerner

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Published by Venkata Rama

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Published by: Venkata Rama on Oct 02, 2012
Copyright:Attribution Non-commercial

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07/19/2015

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04.04.2008 Andrea Hörner 1
Analysis of requirements for a newmarketing authorization applicationfor new chemical entities and newbiological entities
Doktorantenkolloquium im Rahmen derDissertation im Fachbereich Drug RegulatoryAffairs an der Uni Bonn am 04.04.2008
Andrea Hörner, MDRA
 
04.04.2008 Andrea Hörner 2
Topics
General requirements for a newmarketing authorization application
Special requirements per region(EU / USA / Non-ICH selectedcountries)
Conclusion
 
04.04.2008 Andrea Hörner 3
ICH / Non-ICH countries
International Conference of Harmonization (ICH)
European Union
USA
Japan
Non-ICH countries covers all countriesoutside ICH
Î
includesalso Canada,Switzerland & Australia
The ICH countries developed a commonformat for submissions of new marketingauthorization applications (MAAs)
Î
CTDformat

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