Regulatory Open Forum

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EMA and Decentralized Procedure

  • 1.  EMA and Decentralized Procedure

    Posted 24-Jan-2015 07:56
    If one is developing a drug-drug combo product with EU registration intended to proceed via the decentralized procedure, does it ever make any sense to seek scientific advice from the EMA?

    Thank you

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    Heimo Scheer PhD
    Vice President, Regulatory Affairs
    Celerion
    Somerville MA
    United States
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