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Signal management

A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation.

  • LITERO supports your signal detection process by periodic monitoring of sources such as spontaneous reports, clinical studies, and scientific literature in accordance with the guidance on regulatory requirements and on monitoring and reporting processes for signals (GVP Module IX-Signal Management).
  • In addition, we perform signal validation and, if necessary, propose actions such as changes in the product information and/or other risk minimisation measures.
  • In the context of a new signal, we will update your Risk Management Plan as well as the Periodic Safety Update Reports.
  • We will support you with our many years of experience in the creation of relevant SOPs and process development so that you can successfully implement your pharmacovigilance and clinical affairs strategies.
Diagram: Signal management

In the framework of pharmacovigilance, LITERO supports your signal management process by the periodic monitoring of adverse reactions, clinical studies and literature review.

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