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Boston Convention and Exhibition Center

Jun 24, 2018 8:30 AM - Jun 28, 2018 12:00 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

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Evolution and Harmonization of First-in-Human Guidelines

Session Chair(s)

William B. Smith, MD

CEO

Alliance for Multispecialty Research, LLC , United States

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

Speaker(s)

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

PRA Health Sciences, Netherlands

Senior Director, Scientific Affairs - Clinical Pharmacology

Industry Perspective

William Angus, PhD

Biogen, United States

Principal Scientist, Toxicology

Industry Perspective

Sarah Robertson, PharmD

Vertex Pharmaceuticals, United States

Senior Director, Clinical Pharmacology

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DIA 2018 Global Annual Meeting

Evolution and Harmonization of First-in-Human Guidelines

Session Chair(s)

William B. Smith, MD

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

Speaker(s)

Changes to First-in-Human Studies Following the 2017 Revision of the EMA Guidance on Risks for FiH and Early Clinical Trials

Industry Perspective

Industry Perspective

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