Major European research project on monitoring and evaluation of medicines concludes

News 16/02/2015

Symposium will present key findings of the PROTECT project and explore how these can strengthen the assessment of medicines

The European Medicines Agency (EMA) will host and broadcast a symposium on 19 and 20 February to mark the conclusion of the five-year Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) project.

PROTECT's goal is to strengthen the monitoring of the benefit-risk of medicines marketed in Europe by developing innovative methods. It is a public-private partnership of 34 European partners coordinated by EMA and GlaxoSmithKline and funded by the Innovative Medicines Initiative Joint Undertaking. Its partners include national medicines authorities, academic institutions and pharmaceutical companies.

The symposium will take place at the EMA offices in Canary Wharf, London and can be followed live at PROTECT symposium.

The symposium will bring together the results and key recommendations of PROTECT and will discuss how the findings can be applied to improve the monitoring and evaluation of the benefits and risks of medicines in Europe.

More than 230 participants from national medicines authorities, EMA committees, European Union (EU) Member States, academia, industry and patients' associations are registered to attend the symposium.

To help translate research findings into practice, four pre-symposium training courses will take place on 18 February and will provide in-depth training on specific aspects of the research work performed as part of PROTECT.

PROTECT results may significantly influence practices in pharmacovigilance and benefit-risk evaluation. Therefore, during 2015, EMA will systematically scrutinise PROTECT's research outputs in order to identify priority results that are robust and which if implemented, have the greatest potential to positively impact public health.

The objectives of PROTECT

The methods developed by PROTECT are intended to strengthen the monitoring and evaluation of the benefit-risk of medicines marketed in Europe by:

  • enhancing early detection and assessment of adverse drug reactions from different data sources (clinical trials, spontaneous reporting and observational studies);
  • establishing a framework for pharmacoepidemiology studies;
  • examining new methods for data collection from consumers;
  • exploring approaches to integrate benefit-risk methods into scientific assessment of medicines and the subsequent communication of these benefits and risks.

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