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X-WR-CALDESC:Events for CITI Program
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DTSTART;VALUE=DATE:20260914
DTEND;VALUE=DATE:20260919
DTSTAMP:20260723T141439Z
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SUMMARY:2026 NIH Research Festival
DESCRIPTION:The NIH Research Festival showcases the breadth\, innovation\, and impact of research across the NIH community. The event brings together scientists\, staff\, trainees\, contractors\, vendors\, and administrative partners in support of a coordinated effort that highlights research taking place throughout NIH. \nVisit the event page for more information.
URL:https://about.citiprogram.org/event/2026-nih-research-festival/
LOCATION:Main NIH Campus; Building 10 (Clinical Center); 10; Lipsett\, Masur\, FAES Terrace\, FAES Classrooms\, NIH\, 10 Center Drive\, Bethesda\, MD\, 20892\, United States
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260923T083000
DTEND;TZID=America/New_York:20260923T170000
DTSTAMP:20260727T135654Z
CREATED:20260727T135654Z
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SUMMARY:FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics
DESCRIPTION:The FDA’s Center for Biologics Evaluation and Research (CBER) will host a virtual scientific public workshop on September 23\, 2026\, titled “Next-Generation Sequencing (NGS) for Adventitious Agent (AA) Detection in Biologics.” The event will bring together subject matter experts and stakeholders to discuss the readiness of NGS technologies for AA detection\, examine current challenges\, and explore potential approaches to support broader adoption of NGS-based methodologies in biological product testing. \nNGS-based AA detection methods are emerging as new approach methodologies (NAMs) that can help enhance the safety of biological products while reducing reliance on animal testing. Workshop discussions will focus on the use of NGS technologies to detect a broad range of adventitious agents\, including: \n\nViruses\nBacteria\nFungi\nMycoplasma\nParasites\n\nThe event will also address challenges associated with detecting adventitious viruses\, particularly given the genetic diversity of viral populations and the ongoing emergence of new viral variants. These topics are relevant to a range of CBER-regulated biological products\, including cell and gene therapies\, xenotransplantation products\, blood products\, and vaccines. \nWorkshop Objectives: \n\nFacilitate scientific exchange among key stakeholders and regulators regarding current advances in NGS technology and their application to AA detection in biological products.\nGather perspectives on existing methodologies\, implementation challenges\, and emerging technical requirements for NGS-based AA detection.\nUnderstand challenges associated with the adoption of NGS-based methods\, including analytical validation\, data interpretation\, and integration into existing safety testing frameworks.\nIdentify knowledge gaps that must be addressed to support the broader application of NGS-based methods for ensuring the safety of biological products.\n\nVisit the event page for more information.
URL:https://about.citiprogram.org/event/fda-scientific-public-workshop-next-generation-sequencing-for-adventitious-agent-detection-in-biologics/
LOCATION:Online
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DTSTART;TZID=America/New_York:20260923T130000
DTEND;TZID=America/New_York:20260923T140000
DTSTAMP:20260727T140241Z
CREATED:20260727T140207Z
LAST-MODIFIED:20260727T140241Z
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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
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DTSTART;TZID=America/New_York:20260929T084500
DTEND;TZID=America/New_York:20260929T160000
DTSTAMP:20260727T141034Z
CREATED:20260727T141034Z
LAST-MODIFIED:20260727T141034Z
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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
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