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Strategies for Successfully Introducing REMS to Your Organization: From Development and Implementation and Internal and External Evaluation

Speakers

Juliane  Mills, MPH, MSc, MT

Juliane Mills, MPH, MSc, MT

Director Scientific Affairs, Real World Solutions, PRA Health Sciences, United States

Juliane Mills, Director of Scientific Affairs, has a comprehensive understanding of drug development from the laboratory to the patient’s bedside from over 20 years of experience in various scientific roles in academic institutions and industry. She has extensive experience in the operational strategy and scientific design of various study types, such as disease and product registries, post-authorization safety studies (PASS), non-interventional studies, biomarker studies, and chart reviews.

Mary  Willy, PhD

Mary Willy, PhD

Associate Director, Division of Risk Management, OMEPRM, OSE, CDER, FDA, United States

Dr. Willy is Deputy Director for the Division of Risk Management in the Office of Surveillance and Epidemiology in CDER. Dr. Willy received her MPH and PhD from the Johns Hopkins School of Public Health. She joined the FDA in 1998.

Nancy D. Smith, PhD

Nancy D. Smith, PhD

Adjunct Professor, Temple University, FDA Alumni, United States

Nancy Smith, PhD, retired from the FDA after almost 25 years in the Center for Drug Evaluation and Research. Nancy is past-Chair of the Biopharmaceutical Section of the American Statistical Association, and she served as a DIA board member of from 2002-2008. She was Chair of the DIA Annual Meeting in San Diego in 2009.

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