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Signal Management: Separating Needles From Haystacks
Session Chair(s)
William Gregory, PHD
Senior Director, Safety and Risk Management, Pfizer Inc, United States
The session will discuss signal management throughout the lifecycle and how to transition from the pre-approval to the post approval setting. In the post-approval setting, we will concentrate on signal management requirements in EudraVigilance and provide some examples of how companies are addressing the requirements.
The speakers have broad experience and represent the perspectives of CROs, large pharma and small biotech companies.
Learning Objective : Describe the key elements of a signal management process throughout the lifecycle; Identify the requirements of signal management in EudraVigilance and formulate best practices.
Speaker(s)
Uwe Peter Trinks, PHD, MS
Global Practice Lead, PV Technologies, IQVIA , United States
Experiences with the EVDAS Requirements
Rosa Piccirillo, MD
VP and Global Head, Medical Safety, Core Safety Services, IQVIA, United States
From Clinical Trial to Post-Marketing Signal Management: A Continuum
Mick Foy
Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Latest Initiatives with Signal Detection and Management at MHRA
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