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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ICH 30th Anniversary Series: Advancing Pharmaceutical Safety

Session Chair(s)

Amanda Marie Roache, MS

Amanda Marie Roache, MS

Senior Director, 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)

John  Leighton, PhD

Regulatory Perspective: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals

John Leighton, PhD

FDA, United States

Director, Division of Hematology Oncology Toxicology, OOD, OND, CDER

Daniel M Lapadula, PhD

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

Douglas  Keller, PhD

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

David  Strauss, MD, PhD

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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