ICH E19 public consultation

A new ICH-E19 draft guideline on the optimisation of safety data collection in interventional clinical trials and non-interventional studies has been published by ICH for public consultation. The guideline objective is to provide internationally harmonised guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such approach would be implemented. Comments should be submitted by 29 September 2019 to the following email address: ich@ema.europa.eu.

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» ICH E19 public consultation version

» EMA public consultations

EU PAS Register: 1,500 studies registered in April 2019

The 1,500th study was registered in the EU PAS Register (study EUPAS29415) in April 2019. This study, titled 'Observational Patient Evidence for Regulatory Approval and uNderstanding Disease' (OPERAND), looks at the replicability of two RCTs with observational data and is conducted in the US by Harvard Pilgrim Health Care Institute, illustrating the increasing globalisation of the EU PAS Register. The register is key to supporting transparency in post-authorisation research: by April 2019, 46% of the registered studies were requested by regulators, 10% were imposed as a condition of marketing authorisations (i.e. EU RMP category 1 and 2 studies) and 84% of those eligible had their protocol and abstract of results posted in the EU PAS Register. By facilitating the review of protocols and results, the EU PAS Register is also increasingly used for academic research.

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» EU PAS Register

ENCePP webinar 19 March 2019

The meeting report and presentations from the ENCePP webinar (organised by Agenzia Regionale di sanità Toscana) have been published and may be consulted in the documents section of the ENCePP website.

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» ENCePP Plenary Meeting Reports

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.

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

ENCePP activity report 2018

The ENCePP Secretariat has published a summary of the network's activities in 2018. The report provides a list of key achievements, a number of metrics relating to the network's expertise and experience, plus some website statistics.

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» Work plans and activity reports