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ZEG Berlin GmbH

Zentrum für Epidemiologie und Gesundheitsforschung

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      • Menopause Rating Scale (MRS) – Languages
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Crisis Management

Amid a safety crisis, you need an expert with a cool head

Despite best efforts to describe risks and benefits of medications before market introduction, some rare or very rare risks may be too small to describe or predict with certainty. An unexpected serious adverse event or death may generate a safety signal requiring additional pharmacovigilance or pharmacoepidemiological studies in response to a safety alert. Even medicines used for decades may suddenly face unexpected adverse reactions, potentially leading to withdrawal from the market and liability litigation.

ZEG Berlin can assist you during a safety crisis, providing expert advice and opinion on how best to clarify the safety concern and determine if further action is required. In collaboration with your pharmacovigilance and epidemiological teams, we can develop targeted studies to quickly and effectively address stakeholder concerns. Some examples of work we have previously undertaken in this area include:

  • Cyproterone acetate (CPA) and increased risk of liver cancer
  • Combined oral contraceptives and risk of thromboembolism (“pill-crisis”)
  • Simple analgesics and risk of end-stage renal failure

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Expertise

  • Non-interventional study design
  • Post-authorization safety studies
  • Post-authorization efficacy studies
  • Cohort studies
  • Case-control studies
  • Medical Devices
  • Patient Reported Outcomes (PROs)
    • Aging Male Symptoms Scale
    • Menopause Rating Scale
    • Scale for Quality of Sexual Function
    • Short Term Hormone Effect Scale
    • Research team
  • Data collection instruments

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ZEG Berlin

Berlin Center for Epidemiology and Health Research

Invalidenstraße 115
10115 Berlin
Germany

Contact Us

Expertise

  • Real-World Evidence
  • Non-interventional study design
  • Post-authorization safety studies
  • Post-authorization efficacy studies
  • Cohort studies
  • Case-control studies
  • Medical Devices
  • Patient Reported Outcomes (PROs)
  • Data collection instruments

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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Impressum

Website by Laura Yeffeth.