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

Nature Reviews Drug Discovery

Volumn 14, Issue 4, 2015, Pages 221-222

  Haas, Manuel ^a   Mantua, Valentina ^b   Haberkamp, Marion ^c   Pani, Luca ^b   Isaac, Maria ^a   Butlen Ducuing, Florence ^a   Vamvakas, Spiros ^a   Broich, Karl ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b ITALIAN MEDICINES AGENCY   (Italy)

^c Bundesinstitut fur Arzneimittel und Medizinproducte   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ALZHEIMER DISEASE; BENEFIT RISK ASSESSMENT; CONCEPTUAL FRAMEWORK; EUROPEAN MEDICINES AGENCY; HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLIC-PRIVATE PARTNERSHIP; REVIEW; RISK ASSESSMENT; STRATEGIC PLANNING; DRUG INDUSTRY; EUROPEAN UNION; INTERNATIONAL COOPERATION;

ALZHEIMER DISEASE; DRUG INDUSTRY; EUROPEAN UNION; HUMANS; INTERNATIONAL AGENCIES;

EID: 84926395024     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd4585     Document Type: Review

References (6)

1. Qualification opinion of Alzheimer's disease novel methodologies/biomarkers: http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural-guideline/2011/02/WC500102018.pdf
2. Qualification opinion of novel methodologies in the pre-dementia stage of Alzheimer's disease: cerebrospinal fluid related biomarkers for drugs affecting amyloid burden: http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural-guideline/2011/05/WC500106357.pdf
3. 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: http://www.ema.europa.eu/docs/en-GB/document- library/Regulatory-and-procedural-guideline/2011/12/WC500118737.pdf
4. 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: http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and- procedural-guideline/2011/12/WC500125019.pdf
5. Qualification opinion of a novel data driven model of disease progression and trial evaluation in mild and moderate Alzheimer's disease: http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and- procedural-guideline/2013/10/WC500151309.pdf
6. EMA Discussion Paper: http://www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2014/10/WC500176827.pdf