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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
News article7 March 2019European Medicines Agency

Review article about ENCePP Code of Conduct published

For more than 10 years EMA has been at the forefront of scientific independence and transparency in real world data studies through ENCePP. A review article about Revision 4 of the ENCePP Code of Conduct has been published in Pharmacoepidemiology and Drug Safety where patients, academia, contract research organisations, regulators and manufacturers provide their perspectives on ten years of stakeholder experience with non-interventional post-authorisation studies for regulatory purposes.

ENCePP recommendations are also compared with ISPE Good Pharmacoepidemiology Practices and the Code of Conduct published by the ADVANCE project on collaborative vaccine studies.

 

Related information:

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

Details

Publication date
7 March 2019
Author
European Medicines Agency