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Regulatory and HTA Considerations When Using External Evidence to Support Single Arm Trials During Global Drug Development
Session Chair(s)
Solange Corriol-Rohou, DrMed, MD, PhD
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
AstraZeneca , France
Single Arm Trials (SATs) are an important tool for drug development. The session while focusing on EMA and FDA guidance documents on SATs, will discuss how external information can support the needs and expectations of regulators and HTA globally.
Learning Objective : Identify the appropriate settings and considerations for using external evidence in designing single-arm trials; Discuss strategies for advancing global drug development with single-arm trials, addressing differing perspectives among regulators and between regulators and HTA representatives.
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