PPT-Digital health technology-derived clinical outcome assessments: considerations for regulatory

Elektra Papadopoulos MD MPH Acting Deputy Director Division of Clinical Outcome Assessment Office of New Drugs CDER FDA Disclaimer Views expressed in this presentation are those of the speaker and do not necessarily represent an official FDA position. Who am I? . What skills do I have?. What skills do I need?. Definition. Assessment . Is the act of appraising. Is the process of getting information. Definition. Each job seeker is unique and brings. November 2014. Derived Quantities. 2. Derived quantities are . produced using data from kernels. These are the primary reason that SPICE exists!. . Examples . are:. Lighting conditions. Surface intercept (LAT/LON). We can sketch the graph of the derived function f `(x) by looking at the features of the graph of f(x). . This is a simple strategy but does require an understanding that you are drawing the graph of f `(x) from the graph of f(x).. Generated Clocks. The HCC generates two clocks from the . ePLL. 160 MHz clocks and the chip 40 MHz clock, used as a reference:. An 80 MHz clock using a divide by 2 circuit that contains no loops and so is self clearing.. . JiTT. . Quiz. . Think-pair-share . 1-minute paper. Clickers with peer discussion. Group work followed by report-out. Jigsaw. Concept . maps. . Homework. Projects. . Many others!. Formative assessments have multiple roles in the classroom. Peter Murray. Beliefs and Values. Digitising Images. Examples of physical and digital artworks.. Explanation of hardware used to digitise artworks. Scanners. Cameras. Google Art Project. http. ://www.googleartproject.com. Health and Physical Activity Institute. 2012. Dr. Susan Nye. nyesb@jmu.edu. As Deb . Tackmann. said. Real . Relevant . Right Now. Active Student Learning. William . Glasser. once said: “We learn…. Carolyn Compton, M.D., Ph.D.,. CEO and . President. Critical Path Institute . (. C-Path). IOM Workshop International Regulatory Harmonization. Washington, DC. February 13, 2013. The Global Challenge. WHO Technical Briefing Seminar on Essential Medicines and Health Products. 31 October 2013. WHO Headquarters, Geneva, Salle M 505. Dr Claudia P Alfonso . Outline. Global overview of vaccine production and immunization . Carolyn Compton, M.D., Ph.D.,. CEO and . President. Critical Path Institute . (. C-Path). IOM Workshop International Regulatory Harmonization. Washington, DC. February 13, 2013. The Global Challenge. What is WIDA? WIDA stands for World - Class Instructional Design and Assess ment. The WIDA consortium is a group of states dedicated to the design and implementation of high standards and equi of. human . challenge trials. Nele Berthels. FAMHP Vaccine Symposium. , . BRUSSELS, . 9 September 2017. Disclaimer. This presentation . reflects . my . personal point of . view, . and . not necessarily the . Inês Reis – Statistical assessor MHRA. PSI Career Young Statistician Webinar Session – 9 June 2020. Disclaimer. The views expressed in this presentation are my own and should not be understood or quoted as being made on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA) or any other entity.. Kuntz M, Kohlfürst DS, Feiterna-Sperling C, Krüger R, Baumann U, Buchtala L, et al. Risk Factors for Complicated Lymphadenitis Caused by Nontuberculous Mycobacteria in Children. Emerg Infect Dis. 2020;26(3):579-586. https://doi.org/10.3201/eid2603.191388.