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. Prepared for:. Agency for Healthcare Research and Quality (AHRQ). www.ahrq.gov. This presentation will:. Propose primary and secondary outcomes that directly correspond to research questions. Provide clear and objective definitions of clinical outcomes. 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. PI: Geoff Manley, MD, PhD. Outcomes Core Lead: Michael McCrea, PhD. Co-Leads: Murray Stein, MD, Joseph Giacino, PhD, Harvey Levin, PhD, . Sureyya. . Dikmen. , PhD, John Whyte, MD, PhD. (. DoD. CDMRP Award# . 1. 24. th. EPSO Conference. 26 September 2017. Adj Assoc Prof (Dr) Raymond Chua. Group Director (Health Regulation Group), Ministry of Health. Overview of Regulatory Landscape. 2. Ministry of Health (MOH). Marcia Reinhart, DPhil CMPP. Principal, Tantalus Medical Communications. Many definitions. H. ealth . T. echnology . A. ssessments. “Technology assessment in health care is a multidisciplinary field of policy analysis. It studies the medical, social, ethical, and economic implications of development, diffusion, and use of health technology.” . Marcia Reinhart, DPhil CMPP. Principal, Tantalus Medical Communications. Many definitions. H. ealth . T. echnology . A. ssessments. “Technology assessment in health care is a multidisciplinary field of policy analysis. It studies the medical, social, ethical, and economic implications of development, diffusion, and use of health technology.” . wwwdebevoisecomTMT Insights ownership and use Of particular interest is the right to create and use 147derived data148 also known as 147processed data148 or 147resultant data148 creation of derived d S EVENT Y - FIFTH A 7 5 / A/ CONF ./ 9 A genda item 1 6 . 2 24 May 20 22 Strengthening clinical trials 1 to provide high - quality evidence on health interventions and to improve research quality an July 2017 2 Digital Medicine Innovation Quality Assurance / Regulation / Sentinel Coding Pricing Coverage Liability Interoperability Professional Development / Training Will I get paid? Will I ge Elektra Papadopoulos, . FDA/CDER. Lindsay Kehoe, . CTTI. Brian Perry, . CTTI. July 27, 2021. Digital health technology-derived clinical outcome assessments: considerations for regulatory decision-making. Literature review . Interim Report. May . 2022. Authors. Dr Hadi Daneshvar, Dr Hannah Carver, Professor . Catriona Matheson, Professor Tessa Parkes, Mr Joe Schofield and . Mr Graeme Strachan.. How digital technologies have been used to support people who use drugs or their families and carers?. 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.. Practice . Alex Haugh and Vicki Macdonald. Walkergate. Park, . Cumbria. , Northumberland, Tyne and Wear NHS Foundation . Trust. 30th Jan 2020. #CNTWAHP. A little about us….. We work in Neurorehabilitation at a specialised centre..