Regulatory Focus™ > News Articles > Five-Year European Pharmacovigilance Project Comes to an End

Five-Year European Pharmacovigilance Project Comes to an End

Posted 16 February 2015 | By Michael Mezher 

Five-Year European Pharmacovigilance Project Comes to an End

A five-year long European research project to improve drug monitoring methods is coming to a close this month.

The project, known as the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT), is a joint effort by 34 public and private partners and coordinated by the European Medicines Agency (EMA) and GlaxoSmithKline.


PROTECT was launched in 2009 after receiving funding from the Innovative Medicines Initiative (IMI) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), each of whom contributed approximately €11 million to the project. PROTECT participants include European-based pharmaceutical companies, academic institutions, and regulatory authorities.

The goal of PROTECT is to develop methods to “strengthening the monitoring of the benefit-risk of medicines in Europe.” To achieve its goal, PROTECT has broken up its activities into seven work programs:

  • WP1: Project management and administration
  • WP2: Framework for pharmacoepidemiology (PE) studies
  • WP3: Methods for signal detection
  • WP4: New methods for data collection from consumers
  • WP5: Benefit-risk integration and representation
  • WP6: Replication studies
  • WP7: Training and Communication


During its five-year run, PROTECT has published a number of documents and tools related to pharmacovigilance, such as an adverse drug reactions database and a web portal dedicated to benefit-risk assessments.

2015 and Beyond

Now that the PROTECT project is ending, EMA will host a symposium on 19 and 20 February 2015 to present the major outcomes of the project. The symposium will be live broadcast on 19 February 2015 from 9:00 am to 6:00 pm GMT and on 20 February 2015 from 8:30 am to 3:00 pm GMT. A video recording will be uploaded to EMA’s website after the event is concluded.

EMA has said the findings “may significantly influence practices in pharmacovigilance and benefit-risk evaluation. The agency plans to conduct a thorough review of PROTECT’s findings in 2015 to “identify priority results [that] have the greatest potential to positively impact public health.”


EMA Press Release, Symposium Details

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