Wednesday, June 26 • 4:15pm - 5:30pm
#387: Global Perspective on ICH E8(R1): General Considerations for Clinical Trials

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Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-677-L04-P; CME 1.25; IACET 1.25; RN 1.25

Experts from the ICH E8(R1) working group provide an overview of the revisions to the ICH E8(R1) guideline on General Considerations for Clinical Studies and discuss how the revised guideline will support improved study design and conduct.

Learning Objectives

Discuss how the revised ICH E8 Guideline on General Considerations for Clinical Studies will modernize guidance for clinical study design; Describe how to identify critical-to-quality factors to support the meaningfulness and reliability of clinical study results; Discuss how the revised guideline will address a broader range of study designs and data sources.


Amanda Marie Roache, MS


Kerstin Koenig, PhD, MSc

Mark S. Levenson, PhD

Joanne Palmisano, MD, FACP

EMA Update
Agnès Saint-Raymond, DrMed, MD

avatar for Kerstin Koenig

Kerstin Koenig

Executive Director, Research and Development Quality, Merck KGaA
Kerstin Koenig, PhD is the Head of Research & Development Quality, Merck Healthcare KGaA, Darmstadt, Germany. In this role, she is responsible for the development and strategic oversight of the world-wide quality assurance and quality management activities in the area of GRP, GLP... Read More →
avatar for Mark Levenson

Mark Levenson

Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER, FDA
Mark Levenson is the Director of the Division of Biometrics 7 in the Office of Biostatistics/Office of Translational Sciences/Center for Drug Evaluation and Research of FDA. At FDA, he has been the primary reviewer or secondary reviewer on many major pre-market and post-market drug... Read More →
avatar for Joanne Palmisano

Joanne Palmisano

Vice President, Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc
Joanne Palmisano, MD, FACP, FRAPS Dr. Palmisano is a global regulatory leader with extensive biopharmaceutical drug development expertise in small molecule and biologics in multiple therapeutic areas. As Vice President Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc... Read More →
avatar for Amanda Roache

Amanda Roache

Operations Research Analyst, OCD, CDER, FDA
Amanda Roache is FDA's ICH Coordinator and has served as an Operations Research Analyst in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration since 2012. Ms. Roache works in CDER's International Program and facilitates scientific exchanges with... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
Head of International Affairs, Head of Portfolio Board MD and qualified Paediatrician. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio... Read More →

Wednesday June 26, 2019 4:15pm - 5:30pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA