BEGIN:VCALENDAR VERSION:2.0 PRODID:-//CITI Program - ECPv6.17.4.1//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-ORIGINAL-URL:https://about.citiprogram.org X-WR-CALDESC:Events for CITI Program REFRESH-INTERVAL;VALUE=DURATION:PT1H X-Robots-Tag:noindex X-PUBLISHED-TTL:PT1H BEGIN:VTIMEZONE TZID:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20250309T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20251102T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20260308T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20261101T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20270314T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20271107T060000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=America/New_York:20260923T130000 DTEND;TZID=America/New_York:20260923T140000 DTSTAMP:20260727T140241Z CREATED:20260727T140207Z LAST-MODIFIED:20260727T140241Z UID:62829-1790168400-1790172000@about.citiprogram.org SUMMARY:Town Hall – Biocompatibility and Chemical Characterization Testing - Extractions DESCRIPTION:The U.S. Food and Drug Administration (FDA) will host a town hall for industry professionals and other interested stakeholders to discuss chemical characterization testing methodologies used to address biocompatibility endpoints for medical devices. The session will focus on approaches for conducting extractions for chemical characterization testing in accordance with ISO 10993-18\, while also highlighting common challenges and practical examples related to these testing processes. \nParticipants will explore considerations for evaluating the potential biological response to device materials within a risk-based framework. Discussions will also address FDA’s ongoing efforts to support biocompatibility assessments in a manner that is intended to be efficient and least burdensome for both medical device manufacturers and regulatory reviewers. \nVisit the event page for more information. URL:https://about.citiprogram.org/event/town-hall-biocompatibility-and-chemical-characterization-testing-extractions/ LOCATION:Online ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/04/fda-logo.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20260928T140000 DTEND;TZID=America/New_York:20260928T150000 DTSTAMP:20260901T134123Z CREATED:20260901T134123Z LAST-MODIFIED:20260901T134123Z UID:62998-1790604000-1790607600@about.citiprogram.org SUMMARY:Free Live Webinar - Understanding the New USG Policy for High-Risk Life Sciences Research DESCRIPTION:Understanding the New USG Policy for High-Risk Life Sciences Research\nMonday\, September 28\, 2026 at 2:00 p.m. ET\nThis webinar explores the scope of the new USG Policy for High-Risk Life Sciences Research prior to the issuance of implementation guidance\, define the key terminology\, such as Dangerous Gain-of-Function Research (DGOF) and International Research of Concern (IROC)\, and provide practical insight into managing research that meets these definitions from the initial proposal\, through the risk benefit analysis and funding process\, and throughout the lifecycle of the project. \nRegister for additional free live webinars and available webinar replays. \n\n \n \n\n\n \n \n \n \n \n This Webinar Has Closed\n \n \n \n Click below to browse our other upcoming webinars. \n \n\n\n\n \n Webinars Catalog URL:https://about.citiprogram.org/event/free-live-webinar-understanding-the-new-usg-policy-for-high-risk-life-sciences-research/ LOCATION:Online ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/02/citi-program-logo.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20260929T084500 DTEND;TZID=America/New_York:20260929T160000 DTSTAMP:20260727T141034Z CREATED:20260727T141034Z LAST-MODIFIED:20260727T141034Z UID:62832-1790671500-1790697600@about.citiprogram.org SUMMARY:FDA’s Drug Registration and Listing Workshop: Compliance\, Regulatory and Submission Updates DESCRIPTION:This SBIA workshop will feature updates from the U.S. Food and Drug Administration (FDA) on establishment registration and drug listing submissions\, including current validation rules\, evolving regulatory requirements\, and compliance considerations. Attendees will have the opportunity to learn about recent developments affecting these processes and hear discussions on strategies for addressing drug amount reporting requirements. \nThe program will also examine FDA’s final rule on Revising the National Drug Code Format and Drug Label Barcode Requirements and its potential impact on future National Drug Code (NDC) formatting. The workshop will conclude with a panel discussion featuring subject matter experts\, providing attendees with an opportunity to explore key regulatory changes\, discuss implementation considerations\, and gain additional insight into current compliance and reporting expectations. \nIntended Audience \n\nRegulatory science and regulatory affairs professionals working on establishment registration and drug listing submissions and data compliance.\nConsultants and vendors assisting industry with Structured Product Labeling (SPL) submissions to FDA.\nHealthcare professionals using drug listing data and downstream databases to access prescribing and labeling information.\nForeign drug manufacturers and importers that manufacture and import drugs for US commercial distribution.\n\nTopics Covered \n\nProviding the latest updates for submitting accurate registration and listing data to avoid submission errors\, deficiency letters\, manual overrides\, and more.\nDiscussing drug amount reporting requirements and compliance outcomes.\nExplaining the final rule Revising the National Drug Code Format and Drug Label Barcode Requirements and the future format of the NDC.\n\nContinuing Education (CE) \nReal-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event. \nThis course has been pre-approved by: \n\nRAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.\nSOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations\, operations or management\, or to the candidate’s clinical research therapeutic area.\nSQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.\nACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.\n\nVisit the event page for more information. URL:https://about.citiprogram.org/event/fdas-drug-registration-and-listing-workshop-compliance-regulatory-and-submission-updates/ LOCATION:FDA White Oak Campus: The Great Room\, Building 31\, 10903 New Hampshire Avenue\, Silver Spring\, MD\, 20993\, United States ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/04/fda-logo.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20260929T093000 DTEND;TZID=America/New_York:20260929T103000 DTSTAMP:20260901T155620Z CREATED:20260901T155620Z LAST-MODIFIED:20260901T155620Z UID:62640-1790674200-1790677800@about.citiprogram.org SUMMARY:Free Webinar Replay - NIH Biospecimens Rule DESCRIPTION:NIH Biospecimens Rule\nTuesday\, September 29\, 2026 at 9:30 a.m. ET\nThis previously played webinar reviews how the NIH Policy on Enhancing Security Measures for Human Biospecimens follows a broader federal trend toward tightening physical and operational controls on sensitive personal data\, especially in light of DOJ’s bulk-data rule and federal concerns about unauthorized foreign access. This webinar introduces the policy’s rationale\, situates it within NIH’s existing data and research-governance framework\, and outlines the safeguards NIH now expects from institutions handling human specimens. Learners gain a grounded understanding of what the policy covers\, why it emerged\, and what early steps they should consider. \nRegister for additional free live webinars and available webinar replays. \n\n \n \n\n\n \n \n \n \n \n This Webinar Has Closed\n \n \n \n Click below to browse our other upcoming webinars. \n \n\n\n\n \n Webinars Catalog URL:https://about.citiprogram.org/event/free-webinar-replay-nih-biospecimens-rule/ LOCATION:Online ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/02/citi-program-logo.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20260929T110000 DTEND;TZID=America/New_York:20260929T120000 DTSTAMP:20260901T155628Z CREATED:20260901T155628Z LAST-MODIFIED:20260901T155628Z UID:62645-1790679600-1790683200@about.citiprogram.org SUMMARY:Free Webinar Replay - A Behavioral Approach to Compliance DESCRIPTION:A Behavioral Approach to Compliance\nTuesday\, September 29\, 2026 at 11:00 a.m. ET\nThis previously released webinar teaches how behavioral science can enhance compliance programs by exploring human decision-making drivers\, including how to apply a framework to show how to design compliant behaviors\, how to create behaviorally informed strategies\, and how to draw on on practical examples from the #complianceinthewild case studies. \nRegister for additional free live webinars and available webinar replays. \n\n \n \n\n\n \n \n \n \n \n This Webinar Has Closed\n \n \n \n Click below to browse our other upcoming webinars. \n \n\n\n\n \n Webinars Catalog URL:https://about.citiprogram.org/event/free-webinar-replay-a-behavioral-approach-to-compliance/ LOCATION:Online ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/02/citi-program-logo.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20260929T130000 DTEND;TZID=America/New_York:20260929T140000 DTSTAMP:20260901T155647Z CREATED:20260901T155647Z LAST-MODIFIED:20260901T155647Z UID:62648-1790686800-1790690400@about.citiprogram.org SUMMARY:Free Webinar Replay - Being Creative when Applying the IRB Exemptions: Part 2 DESCRIPTION:Being Creative when Applying the IRB Exemptions: Part 2\nTuesday\, September 29\, 2026 at 1:00 p.m. ET\nThis previously released webinar discusses that IRB exemptions are underutilized because many institutions take a very conservative approach when applying them. Through discussion and examples\, this presentation discusses the concept of exemptions and the role they play in regulated and unregulated research. This presentation also points out flexibilities in applying the exemption criteria in categories 4-8 that are often overlooked. \nRegister for additional free live webinars and available webinar replays. \n\n \n \n\n\n \n \n \n \n \n This Webinar Has Closed\n \n \n \n Click below to browse our other upcoming webinars. \n \n\n\n\n \n Webinars Catalog URL:https://about.citiprogram.org/event/free-webinar-replay-being-creative-when-applying-the-irb-exemptions-part-2/ LOCATION:Online ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/02/citi-program-logo.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20260929T140000 DTEND;TZID=America/New_York:20260929T150000 DTSTAMP:20260901T155657Z CREATED:20260901T155657Z LAST-MODIFIED:20260901T155657Z UID:62651-1790690400-1790694000@about.citiprogram.org SUMMARY:Free Webinar Replay - Seven Elements of an Effective Compliance Program: What Research Administrators Need to Know DESCRIPTION:Seven Elements of an Effective Compliance Program: What Research Administrators Need to Know\nTuesday\, September 29\, 2026 at 2:00 p.m. ET\nThis previously released webinar is tailored for IRB\, IACUC\, and sponsored program research administrators. This webinar explores the seven key elements that ensure regulatory adherence\, mitigate administrative risks\, and promote ethical research administration. This session provides practical strategies and case studies as to how to strengthen research compliance programs from an administrative perspective\, operationalize mission\, regulations\, and guidance\, and foster a culture of integrity. \nRegister for additional free live webinars and available webinar replays. \n\n \n \n\n\n \n \n \n \n \n This Webinar Has Closed\n \n \n \n Click below to browse our other upcoming webinars. \n \n\n\n\n \n Webinars Catalog URL:https://about.citiprogram.org/event/free-webinar-replay-seven-elements-of-an-effective-compliance-program-what-research-administrators-need-to-know/ LOCATION:Online ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/02/citi-program-logo.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20260929T151500 DTEND;TZID=America/New_York:20260929T161500 DTSTAMP:20260901T155708Z CREATED:20260901T155708Z LAST-MODIFIED:20260901T155708Z UID:62654-1790694900-1790698500@about.citiprogram.org SUMMARY:Free Webinar Replay - Navigating the Intersection of Open Science and Responsible Conduct of Research DESCRIPTION:Navigating the Intersection of Open Science and Responsible Conduct of Research\nTuesday\, September 29\, 2026 at 3:15 p.m. ET\nThis previously released webinar serves as an introduction to open science principles and practices. It describes what open science is\, how it is related to frameworks for Responsible Conduct of Research\, and the primary rationale for why it is valuable. It then reviews a set of core open science practices—open data\, open code\, open materials\, preregistration\, and open access publishing—highlighting both the benefits and potential limitations of each. The webinar emphasizes that engaging in open science practices is not “all or nothing” and is something that researchers can — and should — begin right away. \nRegister for additional free live webinars and available webinar replays. \n\n \n \n\n\n \n \n \n \n \n This Webinar Has Closed\n \n \n \n Click below to browse our other upcoming webinars. \n \n\n\n\n \n Webinars Catalog URL:https://about.citiprogram.org/event/free-webinar-replay-navigating-the-intersection-of-open-science-and-responsible-conduct-of-research/ LOCATION:Online ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2021/11/citi-program-logo.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20261007T120000 DTEND;TZID=America/New_York:20261007T130000 DTSTAMP:20260828T133341Z CREATED:20260828T133341Z LAST-MODIFIED:20260828T133341Z UID:63165-1791374400-1791378000@about.citiprogram.org 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 ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/09/nih-logo.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20261007T130000 DTEND;TZID=America/New_York:20261007T140000 DTSTAMP:20260828T135800Z CREATED:20260828T135800Z LAST-MODIFIED:20260828T135800Z UID:63168-1791378000-1791381600@about.citiprogram.org 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 ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/04/fda-logo.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20261007T150000 DTEND;TZID=America/New_York:20261007T160000 DTSTAMP:20260828T132043Z CREATED:20260828T132043Z LAST-MODIFIED:20260828T132043Z UID:63163-1791385200-1791388800@about.citiprogram.org 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 ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/09/nih-logo.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20261014T120000 DTEND;TZID=America/New_York:20261014T130000 DTSTAMP:20260902T154920Z CREATED:20260902T154920Z LAST-MODIFIED:20260902T154920Z UID:63199-1791979200-1791982800@about.citiprogram.org 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 ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/04/fda-logo.png END:VEVENT END:VCALENDAR