Post-Marketing Studies

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Post-Marketing Studies

Project description:

Frequently, pharmaceutical companies carry out post-marketing studies (PMS) following market approval of medicinal products and devices. These observational studies are intended to provide scientific insight into the long-term safety, application and interaction of drugs in everyday medical practice. Government regulators use PMS to monitor drug safety and especially to detect rare and very rare side effects. This important task of PMS is legally defined and standardized within the European Union. There is little known about the content and methodological aspects of PMS. The project investigates the practice of PMS to assess its scientific value.

Project management:
Working Group on Health and Working Group on Freedom of Information, Transparency International Germany eV.

Participant at the Institute of Public Health:
Dr. Christof Prugger

Publications:

  1. Spelsberg A, Prugger C, Doshi P, Ostrowski K, Witte T, Hüsgen D, Keil U. Working Group on Health and Working Group on Freedom of Information, Transparency International Deutschland eV.. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies. BMJ 2017;356:j337
  2. Spelsberg A, Keil U, Prugger C. Authors‘ reply to Fralick and Kesselheim. BMJ 2017;357:j1850