Experience and further development with the Voluntary Harmonization Procedure for multinational clinical trials in the European Union

Nature Reviews Drug Discovery

Volumn 11, Issue 5, 2012, Pages 419-

  Krafft, Hartmut ^a   B́lorgey, Chantal ^b   Szalay, Gudrun ^a  

^a PAUL EHRLICH INSTITUT   (Germany)

^b Afssaps Direction de l'Evaluation des Medicaments et des Produits Biologiques ^*  (France)

Author keywords

[No Author keywords available]

Indexed keywords

DATA ANALYSIS; DRUG RESEARCH; ELECTRONIC DATA INTERCHANGE; EUROPEAN UNION; INFORMATION PROCESSING; INTERNATIONAL COOPERATION; LETTER; MULTICENTER STUDY (TOPIC); OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL;

CLINICAL TRIALS AS TOPIC; DRUG DESIGN; HUMANS;

EID: 84860384211     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd3202-c2     Document Type: Letter

References (4)

1. Hughes, B. An audience with. Hartmut Krafft. Nature Rev. Drug Discov. 9, 426 (2010).
2. Amexis, G. & Schmitt, E. A sponsor's experience with the Voluntary Harmonization Procedure for clinical trial applications in the European Union. Nature Rev. Drug Discov. 10, 393 (2011).
3. European Commission. Directive 2001/20/EC. European Commission website [online], http://eur-lex. europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG: 2001L0020:20090807:EN:PDF (2001).
4. Heads of Medicines Agencies (HMA). Guidance document for a Voluntary Harmonisation Procedure (VHP) for the assessment of multinational Clinical Trial Applications: version 2. HMA website [online], http://www.hma.eu/fileadmin/ dateien/Human-Medicines/01-About-HMA/Working-Groups/CTFG/2010-03-VHP-Guidance- v2.pdf (2010).