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Session 4: Global Regulatory Perspective
Session Chair(s)
Daniel Millar, MBA
Senior Director, Strategic Business Transformation
Johnson & Johnson, United States
Zoran Antonijevic, MSc
Vice President, Statistical Consulting
Abond CRO Inc., United States
MaryAnn Morgan-Cox, PhD
Senior Director, Immunology Design Hub
Eli Lilly and Company, United States
Regulatory acceptance is critical to make novel development approaches such as platform trials viable for drug developers and patients. Furthermore, scaling novel approaches to become mainstream requires moving from acceptance to active championship and engagement across stakeholder groups, as well as, a global perspective. In this section, we will explore the global regulatory environment by surveying the interest, openness, and critical challenges foreseen by influential, global regulators with respect to master protocols/platform trials as a patient-centric innovation. Regulatory perspective will span biometrics, clinical review and clinical trial operations.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand current regulators’ interest, openness, perspective on advantages and critical challenges with respect to master protocols/platform trials as a patient-centric innovation
- Identify opportunities where further global alignment could accelerate uptake and implementation
- Identify pathways to engage regulators on innovative proposals for master protocols/platform trials
Speaker(s)
European CTFG perspective on: Complex Clinical Trials
Ditte Zerlang Andersen, PhD, MSc
Danish Medicines Agency (DKMA), Denmark
Senior EU Project Lead
Speaker
Peter P. Stein, MD
FDA, United States
Director, Office of New Drugs, CDER
Speaker
Catherine Njue, PhD
Health Canada , Canada
Manager, Office of Biostatistics
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