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Wednesday, June 22 • 11:15am - 12:15pm
#329: Complex Innovative Design: What’s in Name? A Global Perspective on the Changing Design Landscape

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-618-L04-P ; CME 1.00; RN 1.00

This session will feature international regulators describing the options open for having a Complex Innovative Design agreed. The focus will be on the success of the recent FDA pilot programme, and the current options available through the EMA.

Learning Objectives

Describe the aspects of FDA Complex Innovative Design and be able to foresee how to apply them to their own products; Recognize global differences in the pathways available and the possibility to achieve global harmonisation on complex innovative designs.

Chair

Andrew Thomson, PhD, MA, MS

Speaker

Moderator
Benjamin Hofner, PhD

FDA Update
Dionne Price, PhD

Sponsor Perspective on Interacting with the FDA CID Program: A Case Study
Marius Thomas, PhD



Speakers
avatar for Benjamin Hofner

Benjamin Hofner

Head of Biostatistics, Paul-Ehrlich-Institut, Germany
Benjamin Hofner is Head of Section Biostatistics at the Paul-Ehrlich-Institut (PEI). In this role he is involved in the assessment of Marketing Authorisation Applications and Clinical Trial Applications and provides Scientific Advice to stakeholders. He is Additional Assessor at the... Read More →
avatar for Dionne Price

Dionne Price

Deputy Director, Office of Biostatistics, OTS, CDER, FDA, United States
Dr. Price is the Deputy Director of the Office of Biostatistics. In her role at FDA, she promotes collaborative efforts to advance the use of complex innovative trial designs. An invited speaker at conferences world-wide, she has served as Chair of ASA’s Biopharmaceutical Section... Read More →
MT

Marius Thomas

Senior Principal Biostatistician, Novartis, Switzerland
Marius Thomas, PhD is currently working as a Senior Principal Biostatistician in the Neuroscience development unit of Novartis. Since joining Novartis, he has worked on various projects in the area of multiple sclerosis. Before joining Novartis, Marius was an early-stage researcher... Read More →
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics... Read More →


Wednesday June 22, 2022 11:15am - 12:15pm CDT
Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  11: Statistics, Forum |   02: ClinTrials -ClinOps, Forum