Dr Jens-Ulrich Stegmann | Vice President Head Clinical Safety and Pharmacovigilance
GlaxoSmithKline Biologicals | Belgium

Dr Jens-Ulrich Stegmann, Vice President Head Clinical Safety and Pharmacovigilance, GlaxoSmithKline Biologicals

After completing training as registered male nurse Jens-Ulrich Stegmann studied medicine and completed his M.D. degree from the University of Essen, Germany with a focus on anesthesiology while he did his Internships in Germany and South-Africa. His PhD in Physiology he completed at the Christian Albrechts University, Kiel, Germany
He worked as anesthesiologist at the University of Düsseldorf before starting in the pharmaceutical industry.
He contributed to the development of a number of centrally acting analgesics as clinical lead before he moved into Safety in 2008 having the overall responsibility for different pharmaceutical products and investigational medicines
Jens joined GSK Vaccines in 2012 as Head of Safety Evaluation and Risk Management in Safety and was appointed Deputy QPPV a year later before becoming Head of Clinical Safety and Pharmacovigilance in April 2014.

Appearances:



DC Co-conference Day 2 April 4 @ 11:40

Panel: Improving active vaccine & immunotherapy safety surveillance in resource-limited settings

  • The use of self-control approaches for investigation of vaccine adverse events
    • Examples
  • The need for pharmacoepidemiologic studies to evaluate immune-mediated reaction (IMR) signals in response to checkpoint inhibitor treatment

DC Co-conference Day 2 April 4 @ 3:10

Safety assessment during the clinical development phase of a vaccine

  • Capturing of data
  • Relevance of causality assessment
  • When to build a benefit/risk assessment
  • Different populations vs different approaches

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