The PROTECT Project on Pharmacovigilance Achieves Key Objectives

The PROTECT project, a public-private partnership for innovative methodologies in pharmacovigilance and pharmacoepidemiology coordinated by the European Medicines Agency, has reached a crucial stage with the delivery of two databases which will offer access to important data resources for pharmacovigilance activities and pharmacoepidemiological studies.

The first of these two databases, the Drug Consumption Database, is a comprehensive and structured source of information on drug consumption in Europe. It is the result of reviewing, compiling and updating knowledge about European sources of data on drug utilisation in the out- and in-patient healthcare settings. Information is currently available for 17 EU countries (Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Latvia, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, and The United Kingdom) up to October 2012. Work is in progress to expand data available.

The second database, the PROTECT ADR database, is a listing of all ADRs contained in the section 4.8 of the summary of product characteristics (SmPC) of medicinal products centrally authorised in the EU. It is based on the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The goal of this database is to improve the efficiency of the detection process of ADRs by allowing quick identification and filtering or flagging of listed and unlisted ADR. This database is updated every 6 months and currently contains information up to 30 June 2012.

For further information, please visit:
http://www.imi-protect.eu

About PROTECT
The goal of PROTECT is to strengthen the monitoring of the benefit-risk of medicines in Europe by developing innovative methods. These methods aim to:

  • enhance early detection and assessment of adverse drug reactions (ADRs) from different data sources (clinical trials, spontaneous reporting and observational studies);
  • enable the integration and presentation of data on benefits and risks.

PROTECT is receiving funding from the European Community's Seventh Framework Programme (FP7/2007-2013) through the Innovative Medicine InitiativeExternal link icon. The Agency coordinates the project and manages a multi-national consortium of 33 partners including academics, regulators and companies.

Most Popular Now

Study Finds One-Year Change on CT Scans …

Researchers at National Jewish Health have shown that subtle increases in lung scarring, detected by an artificial intelligence-based tool on CT scans taken one year apart, are associated with disease...

New AI Tools Help Scientists Track How D…

Artificial intelligence (AI) can solve problems at remarkable speed, but it’s the people developing the algorithms who are truly driving discovery. At The University of Texas at Arlington, data scientists...

Yousif's Story with Sectra and The …

Embarking on healthcare technology career after leaving his home as a refugee during his teenage years, Yousif is passionate about making a difference. He reflects on an apprenticeship in which...

AI Tool Offers Deep Insight into the Imm…

Researchers explore the human immune system by looking at the active components, namely the various genes and cells involved. But there is a broad range of these, and observations necessarily...

Highland to Help Companies Seize 'N…

Health tech growth partner Highland has today revealed its new identity - reflecting a sharper focus as it helps health tech companies to find market opportunities, convince target audiences, and...