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ZEG Berlin GmbH

Zentrum für Epidemiologie und Gesundheitsforschung

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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 the 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 pediatric 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

  • Real-World Evidence
  • 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

Contact Us

Services

  • Crisis Management
  • Consulting
  • Data Management and Biostatistics
  • Medical Writing
  • Study Management
  • Quality Assurance
  • Pharmacovigilance

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.

General Data Protection Regulation

With a view to the introduction of the GDPR/EUDSGVO we are glad to present our newupdated privacy policy . The updated description are stored under “about us” and then “privacy policy/GDPR”. Further translation for study participants will follow contemporary.

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