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Session 7 Tracks 1 and 2: Navigating the Testing Strategy for ONTs based on the Updated Q&A’s of ICH E14 and S7B
Session Chair(s)
Jennifer Sisler, PhD
Director, Eli Lilly and Company, United States
Lars Johannesen, MSc
Lead Clinical Analyst, CDER, FDA, United States
The objectives of this session are to focus on the nonclinical and clinical integrated risk assessment strategy for ONTs based on the ICH E14 and S7B Q&As for the potential risk for proarrhythmia. The first talk will provide an overview of the new Q&As, followed by a nonclinical and clinical integrated case study, and ending with how in the future, a potential strategy can be taken to leverage known data to streamline the testing strategy.
Learning Objective : At the conclusion of this session, participants should be able to: - Describe the new Q&As of E14 and S7B
- Explain a case study of an integration on nonclinical and clinical data to inform the potential risk for proarrhythmia of an ONT
- Apply a forward thinking approach for streamlining the risk assessment strategy
Speaker(s)
Speaker
Lars Johannesen, MSc
Lead Clinical Analyst, CDER, FDA, United States
Speaker
YanLing He, DrMed, MD
Executive Director, Novartis, United States
Speaker
Charles Benson, MD, PhD
Vice President Medical Exploratory Medicine and Pharmacology, Eli Lilly and Company, United States