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Shaw Chen

Executive Vice President, Regulatory Affairs
Healthcare
ECLA Estudios Cl?nicos Latinoam?rica
American Samoa

Biography

 Dr. Chen spent over 26 years with the United States Food & Drug Administration (FDA) in new drug development as a primary/supervisory medical staff. He held the position of Deputy Director, Office of Drug Evaluation, Center for Drug Evaluation and Research at the FDA. His achievements included management of new drug review divisions, drafting and implementing FDA guidance for new class drug products and establishing modern drug review agency, as well as educating and training regulatory scientists in the Asian Pacific region. Dr. Chen received his M.D. degree from the University of Miami, and his Ph.D. in Biophysics from Johns Hopkins University. He undertook post-graduate training at Johns Hopkins, Yale University, the University of Minnesota, and the US National Institutes of Health. He authored numerous basic science and clinical papers, as well as drug regulatory guidance publications.

Research Interest

 Dr. Chen spent over 26 years with the United States Food & Drug Administration (FDA) in new drug development as a primary/supervisory medical staff. He held the position of Deputy Director, Office of Drug Evaluation, Center for Drug Evaluation and Research at the FDA. His achievements included management of new drug review divisions, drafting and implementing FDA guidance for new class drug products and establishing modern drug review agency, as well as educating and training regulatory scientists in the Asian Pacific region. Dr. Chen received his M.D. degree from the University of Miami, and his Ph.D. in Biophysics from Johns Hopkins University. He undertook post-graduate training at Johns Hopkins, Yale University, the University of Minnesota, and the US National Institutes of Health. He authored numerous basic science and clinical papers, as well as drug regulatory guidance publications.

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