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Advancing Complex Innovative Clinical Trial Designs – Opportunities for Global Regulatory Convergence in Oncology
Session Chair(s)
Lucia D'Apote, DrSc, RAC
Executive Director Global Regulatory and R&D Policy (ELMAC and JAPAC)
Amgen, Switzerland
This session will provide a platform for scientific exchange among the EMA, other global health authorities (FDA, PMDA), patient advocates, and drug development innovators on a range of Complex Innovative Trial Designs (CID) topics.
Learning Objective : • Foster discussions and education of the use and value of Complex Innovative Trial Designs (CID) within drug development programs • Understand learnings from FDA CID Pilot Meeting Program and experience of other Regulators
Speaker(s)
PDUFA VI Pilot Program: Primary Lessons Learned
Dionne Price, PhD
FDA, United States
Deputy Director, Office of Biostatistics, OTS, CDER
Considerations for Complex Innovative Designs: Case Examples in Oncology
May F Mo, MBA, MS
Amgen, United States
Executive Director, Biostatistics
Panelist
Anja Schiel, PhD
Norwegian Medicines Agency (NoMA), Norway
Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA
Panelist
Christian Schneider, DrMed
PharmaLex, Denmark
Head of Biopharma Excellence and Chief Medical Officer (Biopharma)
Panelist
Frank Petavy, MS
European Medicines Agency, Netherlands
Head of Methodology
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