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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)?

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

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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
26 March 2020

Registration of COVID-19 related studies in the EU PAS Register

 

In these exceptional circumstances, many research groups in Europe and around the world have started or are planning observational studies related to the utilisation and effects of drugs in relation to the Covid-19 pandemic.

In order to support the sharing of information on performed or planned studies and increase the efficiency of research, ENCePP and EMA strongly encourage all researchers to register their pharmacoepidemiological studies related to the Covid-19 pandemic in the EU PAS Register.

Researchers are also encouraged to upload and make public the study protocol with a description of the data collected or planned to be collected in order to facilitate and speed-up the design of observational studies by others.

In order to facilitate the retrieval of studies related to the Covid-19 pandemic, investigators should  include the term “COVID-19” in the study title. Using this term in the field “Title of Study” of the search function will allow retrieval of all registered studies related to the pandemic.

 

Attention is drawn to the following recommendation issued by the International Committee of Medical Journal Editors (ICMJE): In the event of a public health emergency (as defined by public health officials), information with immediate implications for public health should be disseminated without concern that this will preclude subsequent consideration for publication in a journal. We encourage editors to give priority to authors who have made crucial data publicly available (e.g., in a gene bank) without delay.

 

Related information:

»  EU PAS Register®

 

 

 

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