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X-ORIGINAL-URL:https://about.citiprogram.org
X-WR-CALDESC:Events for CITI Program
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DTSTART;TZID=America/New_York:20261007T120000
DTEND;TZID=America/New_York:20261007T130000
DTSTAMP:20260828T133341Z
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SUMMARY:Clinical Center Ethics Grand Rounds: Ethics Of Reducing the Use of Animals In Research
DESCRIPTION:Join the NIH for the “Clinical Center Ethics Grand Rounds: Ethics Of Reducing the Use of Animals In Research” session on October 7\, 2026. This session will be presented by Jayantha Bhattacharya\, MD\, Director at the National Institutes of Health. \nVisit the event page for more information.
URL:https://about.citiprogram.org/event/clinical-center-ethics-grand-rounds-ethics-of-reducing-the-use-of-animals-in-research/
LOCATION:Main NIH Campus; Building 10 (Clinical Center); Lipsett Amphitheater\, 10 Center Drive\, Bethesda\, MD\, 20892\, United States
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DTSTART;TZID=America/New_York:20261007T130000
DTEND;TZID=America/New_York:20261007T140000
DTSTAMP:20260828T135800Z
CREATED:20260828T135800Z
LAST-MODIFIED:20260828T135800Z
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SUMMARY:Town Hall – Biocompatibility and Toxicological Risk Assessment
DESCRIPTION:The U.S. Food and Drug Administration (FDA) will host a town hall for industry stakeholders and other interested parties to discuss toxicological risk assessments used to address biocompatibility endpoints for medical devices. The session will focus on methods and considerations for conducting toxicological risk assessments in accordance with FDA-recognized standards\, as well as examples of common deviations encountered during the evaluation process. \nVisit the event page for more information.
URL:https://about.citiprogram.org/event/town-hall-biocompatibility-and-toxicological-risk-assessment/
LOCATION:Online
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DTSTART;TZID=America/New_York:20261007T150000
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SUMMARY:Beyond the Lab: Insights into Clinical Development in Pharma
DESCRIPTION:Join the NIH for the “Beyond the Lab: Insights into Clinical Development in Pharma” workshop\, presented by Delphine Lissa\, on October 7\, 2026. This webinar is part of NCI’s Science-Based Non-Academic Careers (SNAC) virtual workshop series\, which assists fellows\, staff scientists\, and staff clinicians in exploring non-academic career paths with greater clarity and confidence. \nVisit the event page for more information.
URL:https://about.citiprogram.org/event/beyond-the-lab-insights-into-clinical-development-in-pharma/
LOCATION:Online
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DTSTART;TZID=America/New_York:20261014T120000
DTEND;TZID=America/New_York:20261014T130000
DTSTAMP:20260902T154920Z
CREATED:20260902T154920Z
LAST-MODIFIED:20260902T154920Z
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SUMMARY:Navigating the FDA Bayesian Draft Guidance: Design\, Analysis\, and Review Considerations
DESCRIPTION:Hosted by the FDA’s Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA)\, this event focuses on the Agency’s January 2026 draft guidance\, “Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products\,” which was published to address a PDUFA VII commitment. The guidance outlines key considerations for applying Bayesian methods in clinical trials\, including success criteria and operating characteristics\, the use of external information in prior distributions\, estimands and missing data\, software and computational considerations\, and the documentation and reporting of Bayesian analyses. \nThe program begins with a required pre-recorded video that participants may complete at their own pace before the live panel discussion. The recording provides an overview of the guidance and its implications for the design of clinical trials that use Bayesian methodologies. \nIntended Audience \nClinical trial professionals\, regulatory science professionals\, or regulatory affairs professionals involved in clinical trials and studies where Bayesian approaches may be used. \nTopics Covered \n\nA brief introduction to Bayesian approaches\nSuccess criteria and operating characteristics in Bayesian trials\nConsiderations for prior distributions\nAdditional topics including missing data and estimands\, software usage\, documenting and reporting expectations for Bayesian analyses\nDescriptions of specific settings where Bayesian methods have been previously used.\n\nVisit the event page for more information.
URL:https://about.citiprogram.org/event/navigating-the-fda-bayesian-draft-guidance-design-analysis-and-review-considerations/
LOCATION:Online
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