News for the Industry

09.01.2012
If you want to find about the new regulatory requirements in Europe and USA, we recommend the following websites to you:

Europe

EMEA:
http://www.emea.europa.eu/whatsnewp.htm
http://www.emea.europa.eu/Inspections/WhatsNew.html

CMDh
http://www.hma.eu/186.html

European Commission
http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/new_en.htm

BfArM
http://www.bfarm.de/cln_029/DE/Home/startseite__node.html__nnn=true

PEI
http://www.pei.de/


USA

FDA
A) CDER
http://www.fda.gov/Drugs/NewsEvents/default.htm

B) CBER

http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WhatsNewforBiologics/default.htm



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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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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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    Cologne: Der Regulatory Affairs Manager
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