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ICH 30th Anniversary Series: Advancing Pharmaceutical Safety
Session Chair(s)
Amanda Marie Roache, MS
Senior Director, Science and Regulatory Advocacy
Pharmaceutical Research and Manufacturers of America (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
John Leighton, PhD
FDA, United States
Director, Division of Hematology Oncology Toxicology, OOD, OND, CDER
Industry Perspective: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
Daniel M Lapadula, PhD
Novartis Institutes for BioMedical Research, Inc., United States
Global Head and Vice President, Toxicology
ICH S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines
Douglas Keller, PhD
Sanofi, United States
Global Head for Development Projects, Preclinical Safety
ICH E14/S7B Questions and Answers: Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential
David Strauss, MD, PhD
FDA, United States
Director, Division of Applied Regulatory Science, OCP, OTS, CDER
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