The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
Signal Management: Separating Needles From Haystacks
William Gregory, PhD
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 : Understand what are the key elements to set the foundation for an unique signal management process throughout the lifecycle stage of a product. Understand how the main parameters influencing signal management evolve in both settings as a tool for signal management decision making.
Experiences with the EVDAS Requirements
Uwe Trinks, DrSc, PhD
Partner and Director
Foresight Group, An IQVIA Company, United States
From Clinical Trial to Post-Marketing Signal Management: A Continuum
Rosa A. Piccirillo, MD
Senior Director and Global Head, Medical Safety, Core Safety Services
IQVIA, United States
Major Issues With the New Eudravigilance System (EVDAS) That Were Outlined Within the Recent Q&A Document Published by EMA
Head of Pharmacovigilance Strategy, Vigilance Intelligence and Research Group
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom