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Latin America Regulatory Conference
Session 7: How Can Clinical Trial Innovative Designs Accelerate Medical Innovation for Patients?
Sonia Viejobueno, LLM
- Latin America Lead, Global Regulatory Policy and Intelligence
- The Janssen Pharmaceutical Companies of Johnson & Johnson, Argentina
Renata De Lima Soares
- Regulation and Health Surveillance Specialist
- Anvisa, Brazil
In contrast to traditional trial designs, where a single drug is tested in a single disease population in one clinical trial, designs such as master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple sub-studies, that may contain an adaptive design.
We will discuss Innovative Clinical Trials design, including Basket, Umbrella, Platform and Adaptive Clinical Trials and how they are contributing to accelerate patient access to new medicines and improve the efficiency and the success rate of clinical trials.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand basic concepts of Innovative Clinical Trials Design and their importance for current drug development
- Obtain greater understanding of Innovative Clinical Trials Design and how can industry and regulators across Latin America collaborate to support their implementation in the region
John Scott, PhD, MA
- Director, Division of Biostatistics, OBE, CBER
- FDA, United States
Clinical Trial Innovative designs: Regulatory Agency Perspective
Laura Giselle Traversi, MD
- Head of Clinical Trials Department
- ANMAT, Argentina
Gustavo Mendes Lima Santos, MPharm
- General Manager of Medicines and Biological Products
- ANVISA, Brazil
Telba Irony, PhD, MS, MSc
- Senior Scientific Director, Quantitative Sciences
- Janssen R&D, United States