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Session 6: Signalling: Solutions to current challenges
Session Chair(s)
Menno Van Der Elst, PharmD, PhD
PRAC member
Medicines Evaluation Board, Netherlands
This session will explore the latest developments in signal detection activities in the EU and how the tools provided by the EMA and other data sources are used to support drug safety monitoring. The focus will be on the emergent safety issues (content, threshold, procedure), the latest development/outcome of the pilot by the participants from big or generic companies and the national competent authority point of view on these questions.
Speaker(s)
Emerging Safety Issues – Feedback from the Authorities (PRAC/NCA Perspective)
Menno Van Der Elst, PharmD, PhD
Medicines Evaluation Board, Netherlands
PRAC member
David Matthew Jones
Pfizer R&D UK Ltd, United Kingdom
Safety Process Analyst
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