News 2017

  • 10.03.2017
    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) General http://www.ema.europa.eu b) What's ... More

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  • 08.05.2019
    Mannheim: Aktuelle Trends in der Qualitätskontrolle
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  • 14.-15.04.2019
    Cologne: Der Regulatory Affairs Manager
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  • 16.-17.05.2019
    Vienna: Annex 2 & Co - GMP Compliance for Biopharmaceuticals
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News

  • 10.03.2017
    News for the Industry
    More
  • 26.07.2013
    News on Change Control/Variations:
    More
  • 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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