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Wednesday, June 27 • 8:00am - 9:15am
#309: Evolution and Harmonization of First-in-Human Guidelines

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-629-L04-P; CME 1.25; IACET 1.25; RN 1.25

Revised EMA guidelines for first-in-human studies have been issued. This forum will include a discussion on the significant differences between EMA and FDA guidelines and will include representatives from industry, CRO, and sites.

Learning Objectives

Describe the changes suggested by EMA and FDA with first-in-human guidelines; Describe strategies for implementing these changes.


William B. Smith, MD


Changes to First-in-Human Studies Following the 2017 Revision of the EMA Guidance on Risks for FiH and Early Clinical Trials
Mattheus Paulus van Iersel, MD

Industry Perspective
William Angus, PhD

Industry Perspective
Sarah Robertson, PharmD


William Angus

Principal Scientist, Toxicology, Biogen
Dr. Angus is a Principal Scientist in Toxicology at Biogen. In the past 19 years, he has gained experience in preclinical safety aspects of drug development for stages ranging from target identification through Phase 3 clinical development. He has worked in a variety of project areas... Read More →
avatar for Mattheus Van Iersel

Mattheus Van Iersel

Senior Director, Scientific Affairs - Clinical Pharmacology, PRA Health Sciences
Dr van Iersel is an MD with 25 years of experience in clinical development. He is trained in Clinical Pharmacology in the UK and the Netherlands. Currently he is a Senior Director of Science at PRA. Previously he worked as Researcher at Urology and as Principal Investigator, Medical... Read More →

Sarah Robertson

Senior Director, Clinical Pharmacology, Vertex Pharmaceuticals
Dr. Robertson is a Sr. Director in the Dept of Clinical Development at Vertex Pharmaceuticals, where she has led several early development teams and also served as the Clinical Pharmacologist on many first-in-human and other Phase 1 studies, as well as proof-of-concept and pediatric... Read More →
avatar for William Smith

William Smith

CEO, Alliance for Multispecialty Research/NOCCR
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical... Read More →

Wednesday June 27, 2018 8:00am - 9:15am EDT
Room 156ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: PreClin Dev-EarlyPhaseCR, Session