News 2020

  • 22.03.2020
    News for the Industry
    If you want to find about the new regulatory requirements in Europe and USA, we recommend the following websites to you:  Europe EMA: a) ... More
  • 23.03.2020
    In-house Trainings and Webinars
    NEW!  We now offer all our in-house trainings also as tailor-made webinars. Interaction between you and the speaker is possible, since you can choose from different ... More
  • 24.03.2020
    News on Nitrosamine Impurities
    Risk evaluation needed for all APIs until 26.03.2020! Have you finalized your risk assessment for all your APIs and sent to the Authorities in time? Do you know what's coming next and where to ... More
  • 25.03.2020
    New Deadline for Nitrosamine Impurities
    Risk Evaluation: Extension of Deadline until 1.October 2020 (NEW!) Shortly prior to the deadline of 26.03.20, it was announced that there will be an extension of the deadline to complete ... More

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Events

  • 21.-22.04.2020
    Heidelberg: Handling Changes and Variations
    More
  • 05.05.2020
    Mannheim: Aktuelle Trends in der Qualitätskontrolle
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  • 13.-14.05.2020
    Prague: How to write the Quality Part of an IMPD
    More
Get all events



News

  • 25.03.2020
    New Deadline for Nitrosamine Impurities
    More
  • 24.03.2020
    News on Nitrosamine Impurities
    More
  • 23.03.2020
    In-house Trainings and Webinars
    More
Get all news
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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