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A Strategy for Enhancing Regulatory Acceptance of your QSP Models

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Contributors

  • Chiara Dalla Man (University of Padova)

    Chiara Dalla Man graduated cum laude in Electronics Engineering at the University of Padova in 2000 and received the Ph.D degree in Biomedical Engineering from the University of Padova and City University London, in 2005. She has been a Post-Doctoral Research Fellow with the Department of Information Engineering of Padova University from 2005 to 2007. In 2007 she became Assistant Professor at the University of Padova. Since January 2015 she is Associate Professor in Bioengineering at University of Padova, but since 2013 she was judged by a National Committee to fit for the position of Full Professor in Bioengineering. She is the author of more than one hundred of publications on international journals and 4 International Patents.

  • David Fairman (GlaxoSmithKline)

    Coming soon.

  • Yaning Wang (U.S. FDA)

    Dr. Yaning Wang is the Director of the Division of Pharmacometrics in the Office of Clinical Pharmacology at FDA. Before joining FDA, Dr. Wang received his Ph.D. in Pharmaceutics and master’s degree in Statistics from the University of Florida from 1999 to 2003. He also obtained a master’s degree in Biochemistry (1999) from National Doping Control Center and a bachelor’s degree in Pharmacy (1996) from Peking University in China. Dr. Wang oversees reviews, research projects, and policy development within the Division of Pharmacometrics for all disease areas. During his fifteen years of service at FDA, Dr. Wang received numerous awards, including Award of Merit and FDA Outstanding Service Award. Dr. Wang is an Adjunct Professor in the Department of Pharmaceutics at the University of Florida and an invited lecturer in the College of Engineering and College of Pharmacy at the University of Michigan. Dr. Wang is a regulatory expert lecturer for American Course on Drug Development and Regulatory Sciences (ACDRS) organized by University of California at San Francisco (UCSF), European Course in Pharmaceutical Medicine (ECPM) organized by University of Basel, and Chinese Course on Drug Development and Regulatory Sciences (CCDRS) organized by Peking University Clinical Research Institute in collaboration with University of Basel and UCSF. Dr. Wang served as a committee member for multiple Ph.D. candidates from various universities. He mentored more than thirty former research fellows (visiting scholars, post-doctoral scholars, and Ph.D. candidates) at FDA. Dr. Wang has published over 60 papers and given over 150 presentations at various national and international meetings. He served as a board member of the International Society of Pharmacometrics. He is a member of the Advisory Committee for Chinese Pharmacometrics Society and a member of the Editorial Advisory Board for the Journal of Pharmacokinetics and Pharmacodynamics.

April 19, 2018
Thu 12:30 PM EDT

Duration 1H 30M

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