Latest News

Published: 28 January 2018

 

On 15 January 2018, EMA and European Network of Centres for Pharmacoepidemiology and Pharmacovigilance, ENCePP*, confirmed the membership of our colleague Dr Xavier Fournie 

in the ENCePP Working Group 2 “Independence and transparency”

This working group is chaired for ENCePP by Dr Laura Yates (Consultant in Clinical Genetics at the Institute of Genetic Medicine in Newcastle upon Tyne, Honorary Clinical Senior Lecturer in the Institute of Human Genetics Newcastle University, head of the UK Teratology Information Service) and for the EMA by Dr. Thomas Goedecke, PharmD (Principal Scientific Administrator, Surveillance and Epidemiology Inspections, Human Medicines Pharmacovigilance & Committees Division, EMA). 

Through this active membership, we will strengthen our growing relationships with ENCePP, EMA and other related international societies/stakeholders (e.g., ISPE, efpia), further build on our established scientific and regulatory intelligence, increase EUCROF’s visibility, and gain additional consideration of EUCROF’s perspectives in the development and updating of guidelines and best practice  in peri and post approval clinical research.

This relationship will also support and enhance the dissemination and promotion of pharmacoepidemiology and pharmacovigilance standards to CROs and Industry alike. 

The short term missions of this WG2 include: revision of the Code of Conduct and additional tools to support good governance of pharmacoepidemiological research; improved awareness, functionality and utility of the ENCePP resources database and EU PAS Register.

The ENCePP Work Plan 2017-2019 and the Mandate of WG2 can be found here: 

http://www.encepp.eu/structure/documents/Mandate_WG2.pdf

http://www.encepp.eu/publications/documents/ENCePPWorkPlan2017-2019.pdf

 

*The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) is a network coordinated by the European Medicines Agency (EMA). The members of this network (the ENCePP partners) are public institutions and contract and research organisations (CRO) involved in research in pharmacoepidemiology and pharmacovigilance. Research interests are not restricted to the safety of medicines but may include the benefits and risks of medicines, disease epidemiology and drug utilisation.

 
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.

 

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