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DTSTART;TZID=America/New_York:20200203T083000
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SUMMARY:Advancing EUA IVD Products Toward Full Marketing Status
DESCRIPTION:The Medical Device Innovation Consortium (MDIC) will host a workshop on 3 Feb 2020 to explore key considerations for using real world data to help support in vitro diagnostic (IVD) products available under FDA’s emergency use authorization (EUA) to advance to full marketing status. \nA roadmap for diagnostic evaluations during emergencies would help enable stakeholders to have templates to use to expedite evaluation of laboratory-based tests and point of care technologies. By convening a broad range of government and industry stakeholders\, the goal of the workshop is: \nTo identify challenges and next steps to the use of RWD/RWE to help support the advancement of EUA IVD products to full marketing status. \nThe projected outcomes of the workshop include: \n\nIdentify test case(s) of interest to stakeholders\nDiscussion to inform development of a roadmap for diagnostic evaluations during emergencies\, to include what elements to collect (and how)\nIdentify potential projects or next steps for the test case(s) of interest\n\nKeynote Speakers: \n\nLuciana Borio\, MD; Vice President\, Technical Staff | In-Q-Tel\nNira Pollock\, MD\, PhD; Assoc Medical Director of Infectious Diseases Diagnostic Laboratory at Boston Children’s Hospital\, faculty member of the Division of Infectious Diseases at Beth Israel Deaconess Medical Center\, Boston\, MA.\n\nFDA Speakers: \n\nRADM Denise Hinton\, FDA Chief Scientist\nTimothy Stenzel\, MD\, PhD\, Director\, OHT7: Office of In Vitro Diagnostics and Radiological Health | CDRH\nUwe Scherf\, M.Sc.\, PhD\, Director\, Division of Microbiology Devices\, OHT7: Office of In Vitro Diagnostics and Radiological Health | CDRH
URL:https://globalbiodefense.com/event/advancing-eua-ivd-products-toward-full-marketing-status/
LOCATION:FDA White Oak Campus\, 10903 New Hampshire Ave\, Silver Spring\, MD\, 20993\, United States
CATEGORIES:Conference,Workshop
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20200225
DTEND;VALUE=DATE:20200227
DTSTAMP:20191227T194207Z
CREATED:20191227T194138Z
LAST-MODIFIED:20191227T194207Z
UID:36013-1582588800-1582761599@globalbiodefense.com
SUMMARY:Developing MCMs to Treat Acute and Chronic Effects of Ocular Chemical Toxicity
DESCRIPTION:A U.S. Trans-Agency Scientific Meeting on Developing Medical Countermeasures to Treat Acute and Chronic Effects of Ocular Chemical Toxicity will be held Feb 25-26\, 2020 at the NIAID Conference Center in Rockville\, Md. \nThis meeting\, sponsored by the NIH Chemical Countermeasures Research Program (CCRP) and organized in collaboration with the National Eye Institute (HHS/NIH/NEI) and U.S. Army Medical Research Institute for Chemical Defense (DoD/USAMRICD)\, will bring together subject matter experts from the civilian and military research communities to discuss the current state of the field\, including potential therapeutic approaches and available models. \n\nDevelopment of MCMs that mitigate acute and chronic corneal manifestations in response to ocular toxicants relies on the development of well-characterized experimental models with defined pathophysiology that allow for effective bridging to humans. Such models are also essential to demonstrate therapeutic efficacy. \nAttendees of the workshop will contribute to our understanding of pathologies and models available for studying toxic ocular injuries and their utility in the research and development of therapeutics. Most importantly\, the workshop will address current knowledge gaps to identify possible refinements or new directions to advance MCM development. \n\nHighlighted session topics include: \n\n\nAcute and Chronic Wound Healing Responses to Corneal Toxicity\nMechanistic Basis of Corneal Pathophysiologies\nTherapeutically Accessible Models of Corneal Toxic Injury\nTherapeutic Approaches to Mitigate Corneal Pathophysiologies\nCurrent Research & Development Perspectives and Resources for Researchers\nMeeting Wrap Up \n\n\nPlease visit the NIAID event website for more information. Register by January 31\, 2020. \nEdited by S. Lizotte
URL:https://globalbiodefense.com/event/developing-mcms-to-treat-acute-and-chronic-effects-of-ocular-chemical-toxicity/
CATEGORIES:Workshop
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20200226
DTEND;VALUE=DATE:20200227
DTSTAMP:20200206T192309Z
CREATED:20200206T191959Z
LAST-MODIFIED:20200206T192309Z
UID:38920-1582675200-1582761599@globalbiodefense.com
SUMMARY:Emerging Bioethical Issues in Biomedical Research: A Workshop
DESCRIPTION:A planning committee of the National Academies of Sciences\, Engineering\, and Medicine will conduct a one day workshop on Feb 26\, 2020 to bring together stakeholders to discuss potential ethical issues that may arise from new and emerging trends in biomedical research (including behavioral and social research) and society. \nThe workshop will identify a range of current and emerging bioethical issues – both in basic and clinical research – and explore a broad-range of stakeholder perspectives. Input will be sought from a variety of perspectives which may include patients/participants/individuals\, bioethicists\, academic and industry researchers\, clinicians\, and government representatives. The workshop will describe the state of the emerging science and potential pressing\, recurring\, emerging\, and/or anticipated future bioethical issues in biomedical research and society that fall within the scope of the research and policy activities of the NIH. Potential topics may include: \n\nUse of digital technologies\, artificial intelligence\, and machine learning in biomedical research and clinical care;\nEmerging ethical challenges for sharing data from human research participants and use of human biospecimens;\nHealth equity and health disparities in research\, including:\n\nRecognizing and addressing barriers to participation in research and clinical care across diverse populations and groups\nUnderstanding the impact of cultural and social context on health and disease\nEquitable distribution of the benefits and burdens of research;\n\n\nInnovative study designs\, including crowdsourcing of research and citizen science;\nNovel approaches for enhancing bioethics infrastructure and training;\nNew means for assessing and enhancing scientific workforce diversity; and/or\nInnovative solutions for enhancing research oversight infrastructure.\n\nGiven the broad scope of bioethical issues in research and the difficulty in addressing all possible issues in a single workshop\, the following topics fall outside the scope of this workshop as they are being addressed in multiple other venues: gene editing\, gene drives\, human-animal chimera research\, human fetal tissue research\, neuroethics\, and animal care and welfare. The planning committee will develop the agenda for the workshop\, select and invite speakers and discussants\, and moderate or identify moderators for the discussions. A workshop proceedings will be prepared by a designated rapporteur based on the information gathered and discussions held during the workshop in accordance with National Academies institutional policies and procedures. \nNote: Registration for in-person attendance is full. You may register for the webcast HERE. If you are interested in signing up for the in-person waitlist\, please register HERE and we will contact you if a spot becomes available.
URL:https://globalbiodefense.com/event/emerging-bioethical-issues-in-biomedical-research-a-workshop/
CATEGORIES:Webinar-Webcast,Workshop
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