Programme

Structured Signal Management process as a tool to ensure patients' safety in clinical trials

The session will explore:

  • Signal detection during clinical trials - using small datasets and elements of translational safety
  • Signal validation and assessment - benefits of a robust and well-documented process
  • when a signal becomes an ADR, then a risk, and how to manage it
  • RSI creation/maintenance as output of Signal Management process


About the speaker
Mircea Ciuca

Mircea Ciuca, MD is currently Global Head of Medical & Clinical Drug Safety at Vifor Pharma in Switzerland. He is leading a team of scientists and physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings.
Mr. Ciuca has about 13 years of experience in drug safety. Prior to join Vifor Pharma he held various positions (Deputy QPPV, Senior Pharmacovigilance Medical Manager, Drug Safety Advisor) at large pharmaceutical companies in The Netherlands, after successfully establishing and leading the medical-scientific department of a medium-size CRO in Rotterdam.
After graduating from University of Medicine and Pharmacy in Bucharest Romania, he became specialist in Emergency Medicine, and later in Obstetrics & Gynecology. He was involved in clinical practice and academic teaching for about 12 years. Later he has completed postgraduate studies in Pharmacovigilance at University of Hertfordshire, UK.

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