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ZEG Berlin GmbH

Zentrum für Epidemiologie und Gesundheitsforschung

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Post-authorization safety studies

The rigorous code of conduct set by ENCePP is ZEG Berlin’s standard bearer

All studies by ZEG Berlin adhere to the code of conduct set by ENCePP, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ENCePP’s aim is to strengthen monitoring of the benefit-risk balance of medicinal products in Europe. It achieves this by facilitating high quality, independent, post-authorization studies and developing and maintaining methodological standards and governance principles in research. ZEG Berlin was invited to be a founding partner of ENCePP by the European Medicines Agency. All of ZEG Berlin’s eligible studies have been awarded the ENCePP seal.

Patient data pinpoints the frequency of known and rare adverse events

Post-authorization safety studies (PASS) investigate the frequency of already known adverse events and possible rare adverse events in a patient population that is typical of real-life users. In PASS, the patient is prescribed the drug prior to study entry and according to the therapeutic indication, not protocol. The decision about prescriptions and whether to include the patient in the study are clearly separated. Often the study population includes patients who would otherwise be excluded from clinical trials (e.g. secondary to chronic illness).

The ZEG Berlin European Active Surveillance/International Active Surveillance (EURAS/INAS) study design has been used extensively in PASS since 2000. By asking participants directly about their experiences with the study medication, we can gather data highly sensitive to the outcome of interest. All outcomes of interest are then validated by the treating physician to  ensure that data is robust and specific to your needs. We are also able to include questions at both baseline and follow-up to elucidate important co-variables not easily sourced from electronic databases and registry data (e.g. mood, pain, and breastfeeding).

The EURAS/INAS study design is internationally acknowledged as being scientifically and methodically robust and effective in risk assessment in the post-marketing environment. Scott Monroe, Division Director of the FDA, came to the conclusion that: “The EURAS study could be considered a model study for future post-marketing studies”. In the context of the assessment of Venous Thromboembolic (VTE) risk, comparing different combined oral contraceptives (COCs), the FDA has stated: “The EURAS study is the most rigorously designed prospective cohort study published to date comparing the risk of VTE between different COCs.”

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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

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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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