News 2012

  • 09.01.2012
    News for the Industry
    If you want to find about the new regulatory requirements in Europe and USA, we recommend the following websites to ... More

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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.

News

  • 09.01.2012
    News for the Industry
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  • 19.04.2010
    EU: GMP-Annex 2 revised - Details defined for biological products including ATMPs
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  • 11.03.2010
    EU: IMPD requirements for the Quality part of biological/biotechnology derived substances defined
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Events

  • 13. - 14.03.2012
    Berlin: Change Control – New Aspects and Best Practices
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  • 15. - 16.03.2012
    Vienna: Handling Changes and Variations
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  • 22. - 23.05.2012
    Cologne: Der Regulatory Affairs Manager
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