18.02.2020

Frankfurt: Nitrosamine Impurities

In this conference you will get to know the relevant aspects of risk mitigation with respect to potential Nitrosamine contamination in drug substances and drug products. Dr. Hiltrud Horn will discuss what has to be considered for manufacturers and what are potential sources of Nitrosamines. You will also see a practical example of risk assessment.

For more information please visit the following website:
https://www.gmp-navigator.com/seminare/gmp-seminar-konferenz/nitrosamine-impurities

(Conference organized by Concept Heidelberg)



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    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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