European Medicines Agency and ENCePP launch electronic Register of Studies

The European Medicines AgencyThe European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have launched the ENCePP E-Register of Studies. This electronic register is a publicly accessible resource for the consultation of pharmaco-epidemiological and pharmacovigilance studies conducted by academic centres and other research organisations.

The purpose of the E-Register is to increase the availability of information on the utilisation, safety and effectiveness of medicines used in clinical practice through a readily accessible database resource.

It will also contribute to reducing publication bias by handling both positive and negative study results in the same manner and promote exchange of information, thereby facilitating collaboration within the scientific community and preventing unnecessary duplication of research.

Registration of studies in the register is voluntary, except for those studies wishing to apply for the status of 'ENCePP Studies', a seal awarded to wholly or partially EU-based, benefit/risk studies that are carried out in compliance with the ENCePP Code of Conduct for independence and transparency and the ENCePP Checklist of Methodological Research Standards. Studies that potentially qualify for this seal must be entered into the E-Register before they commence.

The E-Register of studies can be accessed through the ENCePP website - http://www.encepp.eu/encepp/studiesDatabase.jsp

For all studies included in the E-Register, investigators are required to regularly update the information that is available in the register.

The launch of the E-Register of Studies is the latest milestone achieved by ENCePP, following the adoption of the ENCePP Code of Conduct, the launch for public consultation of the Guide on Methodological Standards for pharmacoepidemiological studies and the launch of an inventory of resources. The ENCePP project, which is led by the European Medicines Agency, is intended to enhance the way medicines are monitored once they have been approved for use in the European Union by facilitating the conduct of high quality, multi-centre, independent, post-authorisation studies.

Most Popular Now

Positive new data for Johnson & Johnson single…

Johnson & Johnson (NYSE: JNJ) (the Company) announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly sp...

GSK and Alector announce global collaboration in i…

GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical...

Tezepelumab granted Priority Review by U.S. FDA

Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelu...

One shot of the Sputnik V vaccine triggers strong …

A single dose of the Sputnik V vaccine may elicit significant antibody responses against SARS-CoV-2, finds a study published July 13 in the journal Cell Reports Medicine...

Are silver nanoparticles a silver bullet against m…

Antimicrobials are used to kill or slow the growth of bacteria, viruses and other microorganisms. They can be in the form of antibiotics, used to treat bodily infections...

"Long COVID": More than a quarter of COV…

In a new study of adults from the general population who were infected with COVID-19 in 2020, more than a quarter report not having fully recovered after six to eight mon...

mRNA vaccines slash risk of COVID-19 infection by …

People who receive mRNA COVID-19 vaccines are up to 91 percent less likely to develop the disease than those who are unvaccinated, according to a new nationwide study of ...

Cancer cells eat themselves to survive

It is the membrane of cancer cells that is at the focus of the new research now showing a completely new way in which cancer cells can repair the damage that can otherwis...

U.S. FDA grants Priority Review for the Biologics …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation for the Biologics Li...

Collaboration between AbbVie, Biogen and Pfizer cr…

The access to the world's largest browsable resource linking rare protein-coding genetic variants to human health and disease was launched through a genetic exome sequenc...

Artificial intelligence could be new blueprint for…

Writing in the July 12, 2021 online issue of Nature Communications, researchers at University of California San Diego School of Medicine describe a new approach that uses...

Anti-tumor agent from the intestine

It is believed to be involved in the development of chronic inflammatory intestinal diseases, to trigger diabetes, to be responsible for obesity, even neurological diseas...