Latest News

Published: 24 October 2017

Applied Clinical Trials published in its Volume 26, Issue 10, a paper called “The Shifting Perspectives on Pharmacovigilance in Europe” including some highlights and a link to the paper prepared by the EUCROF PharmacoVigilance Working Group on the EUCROF website.

http://www.appliedclinicaltrialsonline.com/shifting-perspectives-pharmacovigilance-europe

 
Published: 02 October 2017

According to recent GVP module VI Revision 2, from 22 NOV 2017 non-serious ADRs from the market in Europe should be submitted to EMA/Eudravigilance within 90 days. This new updated GVP module also applies to non-interventional studies.

This may have an impact on on-going studies where non-serious ADRs are collected in CRF but not rapidly reported by sites on a case by case basis through an adverse event report form.

Thus, EUCROF PV working group would recommend relevant persons, such as projects managers and data management units to check the modalities of information exchanges with sponsor PV for ADRs.

Operationalisation may include regular study clinical database extractions (e.g. on a monthly basis) in order for PV to review and populate data to the safety database and submit valid cases in due time to the agency (EMA). 

 
Published: 11 April 2017

On 02 April 2017, EUCROF, represented by Dr Stefano Marini,  was invited at the Round Table on “Access to Innovation & Clinical Research” organized by Pitch World Fast and the Ministry of Health of Algeria, in Algiers.

 
Published: 11 April 2017

On 25 April 2017, EUCROF, represented by Dr Martine Dehlinger-Kremer, has been invited to speak about the new EU Clinical Trials Regulation at “Clinical  Trials in Central &Easter Europe Forum” in Budapest.

 

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