26.-27.06.2019

Vienna: GMP for Advanced Therapy Medicinal Products

In this training course you will get to know the essential aspects of the new GMP-Guideline for ATMPs, considering the specifics during clinical development. You will also learn how to handle challenges from development to marketing of ATMPs. Dr. Hiltrud Horn will provide specific examples for the interpretation of GMP. In addition you will get some insight into US-requirements including specific case studies.

For more information please visit the following website:
https://www.gmp-compliance.org/training/gmp-course-conference/gmp-for-advanced-therapy-medicinal-products-atmp


(Conference organized by Concept Heidelberg)

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Events

  • 29.08.2019
    Frankfurt: Prozessvalidierung - Aktuelle Anforderungen für CMC
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  • 17.-18.09.2019
    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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