Position Papers

18 Nov 2012

Position Paper for Rare Diseases and Orphan Drugs Registries and Databases

BACKGROUND AND PURPOSE OF THE POSITION PAPERRegistries are well-established & commonly-used methods for tracking and reporting clinical outcome, safety, effectiveness and epidemiological endpoints for...

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21 May 2012

EBE Position Paper on Tendering of Biologicals, including Biosimilars

The procurement practice is primarily used for medicines which are genuinely identical, bio-equivalent, multi-sourced and off-patent, i.e., small chemical molecules, so-called generics and their origi...

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31 May 2011

EBE Comments on Concept Paper on Biosimilars Containing Biotech-Derived Proteins as Active Substance

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31 May 2011

EBE Comments on EMA GL on Immunogenicity Assessment of mAbs

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