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ZEG Berlin

Berlin Center for Epidemiology and Health Research

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Post-authorization efficacy studies

Enhancing understanding of therapeutic efficacy under real-use conditions

Post Authorization Efficacy studies (PAES) are increasingly imposed by the European Medicines Agency (EMA) on market authorization. PAES data are used to complement available efficacy data when there are scientific uncertainties over aspects of a medicine’s efficacy, when used within its therapeutic indication. These uncertainties usually concern benefits within a specific sub-population, which may not have been included in pre-market development (e.g. renal insufficiency or paediatric populations). They may also relate to concerns over the long-term benefit, or in the case of vaccines, on the potential impact of herd immunity on efficacy.

ZEG Berlin’s study methodology naturally lends itself to PAES. The collection of primary data within the outpatient clinical environment has been successfully used by ZEG Berlin to conduct efficacy studies in the past. Our EURAS/INAS studies include efficacy outcomes as part of the study design providing real-life data under routine clinical use.

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Expertise

  • Non-interventional study design
  • Post-authorization safety studies
  • Post-authorization efficacy studies
  • Cohort studies
  • Case-control studies
  • Medical Devices
  • Diagnostic tools
  • Data collection instruments

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ZEG Berlin

Berlin Center for Epidemiology and Health Research

Invalidenstraße 115
10115 Berlin
Germany

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Latest News

Seven abstracts accepted for ESC Budapest

Congratulations to our Project Management team!  In May 2018 they will be headed to Budapest to present at the European Society of Contraception.  This year we ... Read More

ENCePP

We are a partner centre of the ENCePP scientific network which is coordinated by the European Medicines Agency. We are dedicated to excellence in research by adhering to the ENCePP Guide on Methodological Standards and promoting scientific independence and transparency. We register studies in the ENCePP E-Register of Studies, a publicly accessible resource for the registration of pharmacoepidemiological and pharmacovigilance studies.

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