11.-12.05.2017
Kopenhagen: API Regulatory Starting Materials
In this training course about the Regulatory Affairs Know-how of Active Pharmaceutical Ingredients (APIs), Dr. Hiltrud Horn will give detailed insight into the specifications and impurity of APIs with focus on the regulatory requirements. Furthermore, she will show you the aspects of a successfully strategy and the correct approach for APIs from third countries.
Get precious advice for your CMC-dossiers. Learn from the expert what is really relevant for the IMPD/CTD and what are critical points of discussion.
For more information please visit the following website:
https://www.gmp-navigator.com/daten/seminarpdf/ECA-API-Regulatory-Starting-Materials.pdf
(Conference organized by Concept Heidelberg)
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