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HORN Pharmaceutical Consulting
CMC – GMP – Regulatory Affairs
Dr. Hiltrud Horn 
Am Alten Schloß 1
D-76646 Bruchsal
Germany

Phone: +49 (0) 7251/305 527
Fax:     +49 (0) 7251/305 528
Mobile: +49 (0) 160/5834 213
E-mail: hiltrud.horn@horn-pharma.de

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Phone +49 (0) 7251/305 529
Fax +49 (0) 7251/305 528
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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
    More
  • 11.03.2010
    EU: IMPD requirements for the Quality part of biological/biotechnology derived substances defined
    More
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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
    More
  • 22. - 23.05.2012
    Cologne: Der Regulatory Affairs Manager
    More
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