4th European Clinical Quality Risk Management Forum
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Tuesday, February 25 • 10:45am - 11:45am
PANEL DISCUSSION - Issue Management

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Discuss How to Effectively and Appropriately Manage Issues and Determine Their Severity 
  • Examine available guidelines and regulations on serious breach
  • Assess the impact of EUCTR on issue management and serious breach
  • Strategize on how to determine what should and should not be classified as a serious breach
  • Review various examples of issues and discuss how they were handled

avatar for David Fryrear

David Fryrear

Senior Vice President, Head of Clinical and Research Quality Assurance, ASTELLAS
David Fryrear, M.S., is the Medical and Development organization’s senior vice president and head of the Clinical and Research Quality Assurance (CRQA) organization and has responsibility for providing the global vision, leadership and strategic direction of CRQA at Astellas.Fryrear... Read More →
avatar for Karen Hue

Karen Hue

Quality Assurance Director, Europe, AIMMUNE THERAPEUTICS
Karen graduated with a B.Sc. in Applied Biology specialising in pharmacology followed later on with a diploma in total quality management. Her career started in toxicology in preclinical research followed by a short spell working in transplantation in Addenbrooke’s and Papworth... Read More →
avatar for Heike Reinstaedtler

Heike Reinstaedtler

Head, Clinical and Medical Quality, GSK VACCINES
Heike serves as Head of Clinical and Medical Quality at GSK Vaccines, a global team responsible for quality oversight and support enabling proactive, integrated and risk-based quality management throughout the clinical and epidemiology study processes. Her focus is to partner with... Read More →

Tuesday February 25, 2020 10:45am - 11:45am