Real world monitoring of COVID-19 treatments and vaccines: EMA takes the lead.

 In Drugs

Over the past few months, the European Medicines Agency (EMA) has set up an infrastructure with 3 academic and private partners to support the correct monitoring of efficacy and safety of COVID-19 treatments and vaccines once approved by the agency.

CONSIGN Project – Partners: Utrecht University and University Medical Center Ultrecht – July 2020

The “COVID-19 infectiOn aNd medicineS In preGNancy” will collect data on the impact of COVID-19 in pregnancy, in collaboration with the ConcePTION symposium who aims to reduce uncertainty about the effect of medication used during pregnancy. According to the Agency, CONSIGN will “analyse existing data sources (e.g. electronic health records, hospital data) and cohorts of pregnant women to provide information on the effect of infection and its treatments in different trimesters of pregnancy and on neonates.”

Multicentre cohort studies – Partner: IQVIA – June 2020

In collaboration with the European Health Data & Evidence Network (EHDEN) consortium, the project’s objective encompasses, amongst others:

  • Identification of large national cohorts of COVID-19 patients and appropriate comparator groups, 
  • Development of a study protocol template for multinational studies,
  • Establishment of a collaborative framework for researchers.

ACCESS Project – Partners: Utrecht University and University Medical Center Ultrecht – May 2020

vACcine Covid-19 monitoring readinESS is a public-academic partnership of 22 European research centres, to conduct preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice.

Other specific actions from EMA

– The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) has recently published the 8th revision of the ENCePP Guide on methodological standards in pharmacoepidemiology. This revision intends to guide obtention of valid results to be used by clinician and regulators during COVID-19 observational studies.

– The ENCePP set up a dedicated COVID-19 response group to ensure transparency of protocols and results from post-marketing observational studies.

– EMA, as a member of the International Coalition of Medicines Regulatory Authorities (ICMRA), committed to foster international cooperation in pregnancy research, international clinical cohort of COVID-19 patients coordination and monitoring the safety and effectiveness of vaccines.

– In parallel, EMA continues to offer regulatory advice via the COVID-19 EMA pandemic Task Force (COVID-ETF) and other committees, as well as specific operations to facilitate the product approval process.

Read more:

Link to article:

Guidance for medicine developers and companies on COVID-19


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