The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies

Author:

Gini Rosa1ORCID,Fournie Xavier2,Dolk Helen3ORCID,Kurz Xavier4ORCID,Verpillat Patrice5,Simondon François6,Strassmann Valerie7,Apostolidis Kathi8ORCID,Goedecke Thomas4ORCID

Affiliation:

1. Osservatorio di EpidemiologiaAgenzia regionale di sanità della Toscana Florence Italy

2. Global Medical AffairsICON Commercialisation & Outcomes Lyon France

3. Faculty of Life and Health SciencesUniversity of Ulster at Jordanstown Jordanstown UK

4. Pharmacovigilance and Epidemiology Department, Inspections, Human Medicines Pharmacovigilance and Committees DivisionEuropean Medicines Agency Amsterdam The Netherlands

5. Global EpidemiologyMerck Group Darmstadt Germany

6. Mother and Child Health Research Unit IRDUniversite Paris Descartes Paris France

7. PharmacovigilanzBundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Bonn Germany

8. Vice PresidentEuropean Cancer Patient Coalition (ECPC) Brussels Belgium

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference25 articles.

1. Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

2. Scope and Impact of Financial Conflicts of Interest in Biomedical Research

3. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).Guide on Methodological Standards in Pharmacoepidemiology (Revision 7) (EMA/95098/2010) [Internet]. [cited2018Oct 15]. Available from:http://www.encepp.eu/standards_and_guidances/documents/ENCePPGuideonMethStandardsinPE_Rev7.pdf

4. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).ENCePP Checklist for Study Protocols (Revision 3) (EMA/540136/2009) [Internet]. 2016 [cited2018Oct 15]. Available from:http://www.encepp.eu/standards_and_guidances/checkListProtocols.shtml

5. Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies

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