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About ENCePP

Find out more about the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.

 

Are you a company seeking to commission or collaborate in the conduct of a post-authorisation study (PAS)?

Find out more

Do you wish to register a study in the EU PAS Register?

Find out more

Are you considering applying for an ENCePP study seal?

Read a personal account of the ENCePP study approval process

Are you interested in the recommendations from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) on safety signals?

Review the list of signals discussed

 

 

 

Latest News
28 May 2019
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.

 

Related information:

» ICH E19 public consultation version

» EMA public consultations

25 April 2019
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.

 

Related information:

» EU PAS Register

 

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