23.-24.05.2019

Barcelona: 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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Events

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    Frankfurt: Prozessvalidierung - Aktuelle Anforderungen für CMC
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    Copenhagen: Drug Master File Procedures in the EU, the US and Japan
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  • 27.09.2019
    Frankfurt: Regulatorische Anforderungen an Primärpackmittel
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News

  • 10.03.2017
    News for the Industry
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  • 26.07.2013
    News on Change Control/Variations:
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  • 31.01.2013
    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
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EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.
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