EMEA-coordinated PROTECT project has been accepted for funding

The European Medicines Agency (EMEA)The PROTECT project (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) has been accepted for funding by the Innovative Medicines Initiative Joint Undertaking (IMI JU). PROTECT is a collaborative European project aiming to develop innovative methods in pharmacoepidemiology and pharmacovigilance.

The European Medicines Agency (EMEA) coordinates the project and manages a multi-national consortium of 29 public and private partners.

In April 2008, the IMI JU issued its 1st Call offering research grants for projects to be jointly conducted by research groups comprising mainly public organisations (including academia, competent authorities, non-profit patient organisations and small/medium-sized enterprises) and EFPIA companies. Of the 18 call topics, PROTECT addresses topic no 6: Improving and strengthening the monitoring of the benefit/risk of medicines marketed in the EU.

PROTECT will run over five years, with a total funding of EUR 20 million. Half of the funding will be in-kind contributions from the participating EFPIA companies. The target start date of the project is September 2009.

PROTECT will look at limitations of current methods used in pharmacovigilance and pharmacoepidemiology in order to strengthen the monitoring of the benefit/risk balance of medicines marketed in Europe. A set of innovative tools and methods will be developed and validated in specialised Work Packages, including: (i) modern tools of communication to directly collect data from consumers of medicines; (ii) improved tools for early and proactive detection of signals; (iii) a framework for the design, conduct and analysis of pharmacoepidemiological studies; and (iv) methods for continuous benefit/risk monitoring, with a particular emphasis on graphical methods to display benefit/risk profiles.

In addition to PROTECT, the EMEA also contributes to the IMI-funded project Eu2P, which focuses on the development of a comprehensive and flexible pan-European training and education programme for both specialists and non-specialists in the fields of pharmacoepidemiology and pharmacovigilance.

  • The IMI JU is a newly established European body of the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). More information on the IMI JU is available at: http://www.imi-europe.org
  • This press release, together with other information on the work of the EMEA, can be found on the EMEA website: http://www.emea.europa.eu

Most Popular Now

COVID-19 Long-Acting AntiBody (LAAB) combination A…

AstraZeneca's long-acting antibody (LAAB) combination, AZD7442, will advance into two Phase III clinical trials in more than 6,000 participants at sites in and outside th...

Johnson & Johnson announces European Commissio…

Johnson & Johnson (NYSE: JNJ) (the Company) announced the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an Advance Pur...

BioNTech and Pfizer initiate rolling submission to…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lea...

Vir Biotechnology and GSK announce global expansio…

Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody Eff...

Johnson & Johnson initiates pivotal global Pha…

Johnson & Johnson (NYSE: JNJ) (the Company) announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, J...

Regeneron's REGN-COV2 antibody cocktail reduced vi…

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cockta...

Gilead Sciences signs joint procurement agreement …

Gilead Sciences (Nasdaq: GILD) and the European Commission signed a joint procurement agreement (JPA) that will enable rapid and equitable access to Veklury® (remdesivir)...

COVID-19 vaccine AZD1222 clinical trial resumed in…

The Phase I/II clinical trial for the COVID-19 vaccine AZD1222 has resumed in Japan after discussion with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). ...

Popular COVID-19 conspiracies linked to vaccine 'h…

A new study of beliefs and attitudes toward COVID-19 in five different countries - UK, US, Ireland, Mexico and Spain - has identified how much traction some prominent con...

Scientists identify common vulnerabilities across …

In a study published online in Science, an international team of almost 200 researchers from 14 leading institutions in six countries, including France with the Institut ...

Sanofi and Translate Bio mRNA COVID-19 vaccine can…

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced...

Potential COVID-19 vaccines not affected by domina…

Vaccines currently being developed for COVID-19 should not be affected by recent mutations in the virus, according to a new study involving a University of York virologis...