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The European Medicines Agency's strategies to meet the challenges of Alzheimer disease

Nature Reviews Drug Discovery volume 14, pages 221–222 (2015)Cite this article

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Abstract

Regulatory agencies have a key role in facilitating the development of new drugs for Alzheimer disease, particularly given the challenges associated with early intervention. Here, we highlight the strategies of the European Medicines Agency to help address such challenges.

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Author notes

  1. Manuel Haas, Valentina Mantua and Marion Haberkamp: These authors contributed equally to this work.

Authors and Affiliations

  1. European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom

    Manuel Haas, Maria Isaac, Florence Butlen-Ducuing & Spiros Vamvakas

  2. Agenzia Italiana del Farmaco, Via del Tritone 181, Rome, 00187, Italy

    Valentina Mantua & Luca Pani

  3. Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, Bonn, 53175, Germany

    Marion Haberkamp & Karl Broich

Authors
  1. Manuel Haas
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  2. Valentina Mantua
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  3. Marion Haberkamp
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  4. Luca Pani
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  5. Maria Isaac
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  6. Florence Butlen-Ducuing
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  7. Spiros Vamvakas
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  8. Karl Broich
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Corresponding author

Correspondence to Manuel Haas.

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Competing interests

The authors declare no competing financial interests.

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FURTHER INFORMATION

Qualification opinion of Alzheimer's disease novel methodologies/biomarkers

Qualification opinion of novel methodologies in the pre-dementia stage of Alzheimer's disease: cerebrospinal fluid related biomarkers for drugs affecting amyloid burden

Qualification opinion of low hippocampal volume (atrophy) by MRI for use in clinical trials for regulatory purpose - in pre-dementia stage of Alzheimer's disease

Qualification opinion of Alzheimer's disease novel methodologies/biomarkers for the use of CSF AB 1-42 and t-tau and/or PET-amyloid imaging (positive/ negative) as biomarkers for enrichment

Qualification opinion of a novel data driven model of disease progression and trial evaluation in mild and moderate Alzheimer's disease

EMA Discussion Paper

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Haas, M., Mantua, V., Haberkamp, M. et al. The European Medicines Agency's strategies to meet the challenges of Alzheimer disease. Nat Rev Drug Discov 14, 221–222 (2015). https://doi.org/10.1038/nrd4585

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