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Increasing Vigilance Transparency: When is the Right Time to Publish Safety Signals?
Session Chair(s)
Sarah Vaughan
Head of Vigilance Operations
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
A forum sharing different perspectives from international regulators & patients on when is the right time to publish information on safety signals from spontaneous data. We will explore how we can meet patient needs without leaving unanswered questions.
Learning Objective : Discuss the challenges and opportunities that could present for patients from having early access to information on safety signals arising from spontaneous data from international regulators; Assess how patient preferences can be evaluated and incorporated in safety monitoring and risk management communications.
Speaker(s)
Panelist
Niklas Noren, PHD, MSC
Uppsala Monitoring Centre (UMC) , Sweden
Chief Science Officer
Panelist
Representative Invited
FDA, United States
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