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Events

  • 29.-30.10.2019
    Hamburg: How to provide process validation data in regulatory submission
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  • 13.-14.11.2019
    Mannheim: Projektmanagement in Regulatory Affairs
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  • 19.11.2019
    Brugg: MEGRA StartUp
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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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