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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
SCR Consulting, 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.
Speaker(s)
Panelist
Alex Bliu, PhD
Health Canada, Canada
Senior Biostatistician
Panelist
François Houyez
European Organisation for Rare Diseases (EURORDIS), France
Treatment Information and Access Director, Health Policy Advisor
Panelist
Andrew Thomson, PhD, MA, MS
European Medicines Agency, Netherlands
Statistician, Methodology Taskforce
Panelist
Anja Schiel, PhD
Norwegian Medical Products Agency (NOMA), Norway
Special Advisor, Lead Methodologist/Statistician; NOMA
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