EMA Data Expert Discusses Gaps in RWE Framework

October 4, 2021

The European Medicines Agency (EMA) has recognized gaps in guidelines on real world evidence (RWE) submissions. The EMA’s Xavier Kurz recently spoke at Regulatory Affairs Professionals Society (RAPS) Convergence 2021 regarding the importance of RWE and the need for updated submission instructions.

Kurz asked, “What is the purpose of real-world evidence? How is it presented? What is the information that is needed? There is a need for perhaps more consistency,” adding, “And also the structure and the way real-world evidence is submitted needs attention and probably to be given more guidance in terms of standard definitions … or assessment of the quality by the applicants.” Read more here.

(Source: Nick Paul Taylor RAPS, 9/14/21)

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