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ICH 30th Anniversary Series: Advancing Pharmaceutical Safety
Session Chair(s)
Amanda Roache, MS
Deputy Vice President, Science and Regulatory Advocacy , PhRMA, United States
This session will provide an overview of ICH safety topics instrumental to the harmonization of pharmaceutical development standards and an introduction to the new and revised topics that are currently underway.
Learning Objective : Discuss the role of ICH Safety topics in harmonizing standards for more efficient pharmaceutical development and registration;Explain current ICH guidelines being revised, new guidelines being developed, and their anticipated impact to pharmaceutical development.
Speaker(s)
Regulatory Perspective: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
Director, Division of Hematology Oncology Toxicology, OOD, OND, CDER, FDA, United States
Industry Perspective: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
Global Head and Vice President, Toxicology , Novartis Institutes for BioMedical Research, Inc., United States
ICH S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines
Global Head for Development Projects, Preclinical Safety, Sanofi, United States
ICH E14/S7B Questions and Answers: Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential
Director, Division of Applied Regulatory Science, OCP, OTS, CDER, FDA, United States
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