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RAI Center

Mar 04, 2013 9:00 AM - Mar 04, 2013 12:30 PM

Europaplein, 1078 GZ Amsterdam, Netherlands

Tutorial 17: Creating Compliant Clinical Study Reports for the EU and US

Speakers

Teresa  Eastwood-Kiefer

Teresa Eastwood-Kiefer

Global Lead, Regulatory Submission Management, Roche, Switzerland

Teresa Eastwood is a Global Team Leader within Pharma Development Regulatory Operations, Roche, and Product Owner for a centralized Automation 'Factory'. With over 15 years’ in Regulatory Affairs, she is known as an expert in drug application requirements and drug development processes. She is an active lecturer at ETH University and forums. A passionate advocate for innovation, Teresa regularly assesses future trends in industry and technology and proactively translates them into opportunities to increase efficiency. After 9 years in Actelion Pharmaceuticals Ltd., building a regulatory operations function from the ground-up, Teresa found her why when joining Roche in 2014 to bring therapies to patients faster while ensuring patient safety.

Nancy Pire Smerkanich, DrSc, MS

Nancy Pire Smerkanich, DrSc, MS

Assistant Professor Regulatory & Quality Sciences, University of Southern California School of Pharmacy, United States

Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry peers. In her role at USC, she brings many years of practical regulatory knowledge and experience to academia with a focus on clinical translational science. With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas.

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