Identifying and overcoming challenges in the EMA's qualification of novel methodologies: a two-year review

The EMA Qualification of Novel Methodologies procedure qualifies methods, technologies and methodologies within a well-defined context of use in a pharma R&D context based on the evaluation of the presented scientific rationale and submitted data. This policy brief analyses QoNM submissions prov...

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Main Authors: Ana Drmić (Author), Riccardo Saccà (Author), Thorsten Vetter (Author), Falk Ehmann (Author)
Format: Book
Published: Frontiers Media S.A., 2024-11-01T00:00:00Z.
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3rd Floor Main Library

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Call Number: A1234.567
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