Print page Resize text Change font-size Change font-size Change font-size

Welcome to the PROTECT website!

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium is a collaborative European project that comprises a programme to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. The European Medicines Agency (EMA) is the coordinator of PROTECT and GSK is the deputy co-ordinator of PROTECT. They manage a multi-national consortium of 34 partners including academics, regulators, SMEs and EFPIA companies.


Latest News


September 2016

The European Medicines Agency (EMA) evaluates regulatory impact of PROTECT


The EMA has reviewed the key outputs of PROTECT to evaluate how they have been or will be implemented into regulatory practice. This review concludes that PROTECT has achieved the objectives and deliverables of the Call Topic to which the PROTECT consortium applied. In addition, outcomes linked to signal detection and evaluation are being implemented into routine pharmacovigilance and regulatory practice and start to have a positive impact on public health and resources. In the course of this evaluation, a survey tool to measure the public health impact and feasibility of research projects has been developed and piloted.

. The report is available here.


September 2016

PROTECT WP2 new publications added


Two new publications from WP2 are now available throught the PROTECT website, namely:

Afonso A et al: "A methodological comparison of two European primary care databases and replication in a US claims database: inhaled long-acting beta-2-agonists and the risk of acute myocardial infarction" (WP2 WG1) and Schmield S. et al: "Response to Wise et al. (Tiotropium safety in real life populations)" (WP2 WG3).


August 2016


The latest version of the Adverse Drug Reaction database, updated up to 30 June 2015 in now available on the PROTECT website and can be accessed here.


April 2016

PROTECT WP2 on PDS Special Issue.


The Pharmacoepidemiology and Drug Safety journal has published a Special Issue on the IMI-PROTECT WP2. The European Medicines Agency has announced it on its website with links to the main publications and a summary of the main results. You can find all the information here.


September 2015


The latest version of the Adverse Drug Reaction database in now available on the PROTECT website and can be accessed here.


September 2015



PROTECT was part of the 2015's International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE) in Boston with a specific Symposium titled: "PROTECT: The Challenges and Successes". Participants to the Symposium were informed about the most important results of WP2, WP3, WP4 and WP5 and how they may impact pharmacovigilance practice from industry and regulatory perspectives. The difficulties met to recruit directly pregnant women, and the solutions adopted by WP4, were discussed. A framework for evaluating the potential impact of regulatory science projects and the results of a test on PROTECT outputs were presented.  Slides presentations and a poster are available here.


September 2015


The final report of WP4 - New methods for data collection from consumers- is now available on the PROTECT website. In the report, the PROTECT Pregnancy Study team shows that collecting data directly from consumers, such as pregnant women, for pharmacovigilance is feasible and valuable, but not without difficulties.

The report can be accessed through this link.


April 2015


PROTECT Symposium materials

Presentations from the PROTECT Symposium as well as recordings from the event are now available in a specific section of the PROTECT website, which you can access form the left-side menu of the Home page and also from this link.


December 2014


Adverse Drug Reactions Reference Dataset

The ADRs Reference Dataset used by Work Package 3 (WG1 and WG8) is now available in our "Results" section at the specific link to Methods for Signal Detection Reports and Databases.


November 2014


PROTECT Symposium

Visit our news section to know more about the Final Symposium that the European Medicines Agency is organising as a closure event of the PROTECT Project.


September 2014



A new version of the Adverse Drug Reaction database in now available on the PROTECT website and can be downloaded here.


July 2014

PROTECT at ICPE 2014 - updates

PROTECT will present 13 posters, 8 oral presentations and 2 Symposiums at the 30th International Conference on Pharmacoepidemiology and Therapeutic Risk Management -ICPE, which will be held in Taipei (Taiwan, 24th - 27th October 2014).

You can find the complete list of the topics, authors and involved work programmes here.


July 2014
New Publications for the PROTECT project

PROTECT has published two new articles respectively within the work programme on the Framework for pharmacoepidemiology studies (WP2) and the work programme on Benefit-Risk integration and representation (WP5). 

You can find them in our Results section.


March 2014
PROTECT 4th Periodic Project Report

The fourth PROTECT project periodic report covering the period 1 September 2012 to 31 August 2013, endorsed by the Innovative Medicines Initiative last December 2013, is now available on the PROTECT website. Please find a summary in the news section.


February 2014

PROTECT has submitted 26 abstracts to the 30th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), which will be held in Taipei (Taiwan) from 24th to 27th October 2014. You can find more details here.


January 2014
PROTECT WP2/WG3 has published the updated version of the Drug Consumption Databases

The authors have reviewed, compiled, and updated the knowledge about European sources of data on drug utilisation in the out- and inpatient healthcare setting.  Information is available for Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Slovenia, Spain, Sweden, The Netherlands, and The United Kingdom.  Information was last updated December 2013.

Two documents are available.  A master document organised as a scientific article, with a detailed and accurate account of the information already available, methods to retrieve this information, and a discussion.  And, a country profile document with a summary of the relevant information from the masters document: country’s health system, reimbursement characteristics, and a list of websites of interest, summarised by country.

These documents are a shared resource for researchers, regulatory agencies, and pharmaceutical companies. They can be found here.


More news...