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Oct 14, 2014 11:00 AM - Oct 14, 2014 12:30 PM

(Eastern Standard Time)

Online

Seven-Part Series on Pediatric Drug Development - Part 7: Operational Challenges of Pediatric Clinical Trials

Speakers

Alexander  Cvetkovich Muntañola, MD

Alexander Cvetkovich Muntañola, MD

Senior Director Clinical Development, Barcelona Office Site Head, INC Research, Spain

Klaus  Rose, MD, MS

Klaus Rose, MD, MS

Chief Executive Officer, klausrose Consulting, Switzerland

Klaus Rose, a German MD with postgraduate degrees in General & Pharmaceutical Medicine, was 20 years with Big Pharma. In 2001, he became Global Head Pediatrics at Novartis & 2005 at Roche ; CEO of klausrose Consulting since 2011. He advises on pediatric drug development and FDA/EMA pediatric requirements. Private interests: languages, classical guitar, cooking, wine & gardening

Steven  Hirschfeld, MD, PhD

Steven Hirschfeld, MD, PhD

Captain, US Public Health Service, Associate Director for Clinical Research, National Institutes of Health, NICHD, United States

Dr. Steven Hirschfeld is a pediatric hematologist-oncologist who served in the US Federal Government in the Departments of Health and Human Services, Homeland Security, and Defense. His MD is from Columbia University, PhD from New York University, and clinical training at the University of California, San Francisco and the National Cancer Institute. He contributed to development of the CDISC standards and served on the Board of Directors as well the Site Accreditation Standards Initiative and serves on the Board of Directors. He is Professor of Pediatrics at the Uniformed Services University of the Health Sciences, consultant to the National Institute on Deafness and Other Communication Disorders, and does private sector drug development.

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