AB Cube
AB Cube markets the Safety-Easy pharmacovigilance database system.
Powerful and reliable, Safety-Easy is the ideal solution for recording
case data from clinical trials and spontaneous notifications. It is
fully compliant with the requirements of the drug safety authorities
(ICH E2B, MedDRA, CIOMS I, A.S.R, P.S.U.R, etc.).
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Actualités
Changes to legislation
The following consultative document has been published for
comment prior to adoption: STRATEGY TO BETTER PROTECT PUBLIC HEALTH BY
STRENGTHENING AND RATIONALISING EU PHARMACOVIGILANCE..
Click here :
public-consultation_12-2007.pdf
The purpose of the document is to clarify and, more importantly, to
rationalize certain aspects of the current legislation (Directive
2001/83/EC and Regulation 726/2004).
The responses received to this public consultation are available here.
Click here >:
The conclusions of the working group on clinical trials are contained
in the following document: Conference on the Operation of the Clinical
Trials Directive (Directive 2001/20/EC) and Perspectives for the Future
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2007/2007_11/ec_emea_conference_on_clinical%20_trials.pdf
Problems have been encountered in the implementation of directive
2001/20/EC and its interpretation in the national legislation of the
Member States, with the result that it is becoming increasingly
difficult to manage pharmacovigilance data from clinical trials. The
aim of this work group is to provide the industry and other clinical
trial stakeholders in Europe with unambiguous, practical and harmonized
directives regarding all current problems (e.g. different declaration
formats in different countries, case reporting and blind/unblinding
requirements).