Lesley Butler

Lesley Butler

Company: UCB S.A.

Job title: Head of RWE Digital Innovation


Presentation: Tackling the Challenges Associated with Evidence Generation for Clinical Evaluation and Post-Market Surveillance Within the Context of Evolving Global Regulations in a Fast- Paced Industry 4:10 pm

How can we leverage real world data to demonstrate safety and effectiveness of SaMD products during development and post market? What considerations are needed for the use of RWE to in SaMD development and post-market surveillance given FDA guidance and MDR requirements? What multifunctional devices and digital health technologies can pharma organizations and manufactures deliver…Read more

day: Conference Day Two

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