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Wednesday, June 17 • 9:30am - 10:30am
#311 L: ICH 30th Anniversary Series: Advancing Pharmaceutical Safety

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-682-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Amanda Marie Roache, MS


Regulatory Perspective: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
John Leighton, PhD

Industry Perspective: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
Daniel M Lapadula, PhD

ICH S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines
Douglas Keller, PhD

ICH E14/S7B Questions and Answers: Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential
David Strauss, MD, PhD

avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related international regulatory policy, advocacy in... Read More →

Daniel Lapadula

Global Head and Vice President, Toxicology, Novartis Institutes for BioMedical Research, Inc.
New York University - Ph. D. 1981. Assistant Professor, Duke University, 1986. Schering-Plough, Principal Scientist General Toxicology 1990. Sandoz, Assistant Director Toxicology 1991; Director,1995. Exectutive Director, 2005; Global Head and Vice President of Toxicology, 2006.
avatar for Douglas Keller

Douglas Keller

Global Head for Development Projects, Preclinical Safety, Sanofi
Ph.D. in Pharmacology from Duke University. Postdoctoral Fellow at the Chemical Industry Institute of Toxicology. Staff toxicologist at DuPont Haskell Laboratory for 10 years. Joined Sanofi in 1998. Currently Global Head for Development Projects, Preclinical Safety in Sanofi.

John Leighton

Director, Division of Hematology Oncology Toxicology, OOD, OND, CDER, FDA
Dr. Leighton received his PhD from the Department of Physiology and Biophysics at the University of Illinois, Urbana-Champaign. Dr. Leighton first came to FDA as a pharmacology and toxicology reviewer in the Center for Veterinary Medicine and moved to the Division of Oncology Drug... Read More →
avatar for David Strauss

David Strauss

Director, Division of Applied Regulatory Science, OCP, OTS, CDER, FDA
Dr. Strauss is a physician-scientist with experience in experimental and clinical research along with regulatory evaluation for drugs and medical devices. He currently serves as Director of FDA's Division of Applied Regulatory Science, which seeks to move new science into the FDA... Read More →

Wednesday June 17, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session |   01: ClinSafety-PV, Session