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.
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Details
- Publication date
- 7 March 2019
- Author
- European Medicines Agency