Submission of Result-Related Information to the EudraCT Database

Rubrik: europharm

(Treffer aus pharmind, Nr. 08, Seite 1129 (2016))

Peters J | Wolters C | Köhler S | Niestroj M

Submission of Result-Related Information to the EudraCT Database / First Experiences and Common Pitfalls · Peters J, Wolters C, Köhler S, Niestroj M · ¹Bundesverband der Pharmazeutischen Industrie e. V., Berlin und ²Wachenhausen Rechtsanwälte Partnerschaft mbB, Lübeck und ³Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe
The European Union Drug Regulating Authorities Clinical Trials (EudraCT) database was established by the European Medicines Agency (EMA) in May 2004 in accordance with the European Clinical Trials Directive (Directive 2001/20/EC) issued by the European Parliament and the Council [ 1 , 2 ] as a registry for all clinical trials investigating medicinal products for human use in the European Union (EU). In order to obtain regulatory permission to initiate a clinical trial in any member state of the EU, sponsors are required to obtain a study specific, unique EudraCT number based on administrative information entered into the EudraCT database. ...