16.-17.05.2019

Vienna: Annex 2 & Co - GMP Compliance for Biopharmaceuticals

In this two days conference, Dr. Hiltrud Horn will show you what is really important for the development of biotech products. You will learn how to deal with GMP and regulatory aspects.

For more information please visit the following website:
https://www.gmp-compliance.org/training/gmp-course-conference/gmp-compliance-for-biopharmaceuticals


(Conference organized by Concept Heidelberg)

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Events

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    Copenhagen: Drug Master File Procedures in the EU, the US and Japan
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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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