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.
