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X-WR-CALDESC:Events for CITI Program
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DTSTART;VALUE=DATE:20251007
DTEND;VALUE=DATE:20251010
DTSTAMP:20260405T181556
CREATED:20250912T145303Z
LAST-MODIFIED:20250912T145303Z
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SUMMARY:CITI Program to Exhibit at RAPS Convergence 2025
DESCRIPTION:Visit CITI Program at Exhibit Booth #910\nCITI Program will join The Regulatory Affairs Professionals Society (RAPS) at their 2025 Convergence from October 7-9\, 2025. RAPS is the world’s leading organization dedicated to professionals in regulatory and quality roles across the healthcare product landscape\, including medical devices\, pharmaceuticals\, biologics\, diagnostics\, and digital health. \nSession tracks include: \n\nDevices (including Medical Devices and In Vitro Diagnostics)\nPharmaceuticals (including Biologics and Drugs)\nBroad Interest (Cannabidiol\, Health-Related Foods\, AI\, Cybersecurity\, Data Transparency\, Inspections & Audits)\nSkill Building\n\nVisit the conference page for more information.
URL:https://about.citiprogram.org/event/citi-program-to-exhibit-at-raps-convergence-2025/
LOCATION:David L. Lawrence Convention Center\, 1000 Ft. Duquesne Blvd.\, Pittsburgh\, PA\, 15222\, United States
ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/09/raps-2025-2.png
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20251007T090000
DTEND;TZID=America/New_York:20251008T150000
DTSTAMP:20260405T181556
CREATED:20250926T162030Z
LAST-MODIFIED:20251015T175233Z
UID:59206-1759827600-1759935600@about.citiprogram.org
SUMMARY:Advancing Generic Drug Development: Translating Science to Approval 2025
DESCRIPTION:Join FDA experts at the 2025 Advancing Generic Drug Development Workshop\, an in-depth event exploring the transformative impact of the Generic Drug User Fee Amendments (GDUFA) Science and Research Program on generic drug development\, regulation\, and approval. \nThis workshop will cover key scientific and regulatory challenges in abbreviated new drug applications (ANDAs)\, provide insights into GDUFA III progress\, and spotlight innovative research in complex generics. \nKey Topics Include: \n\nResearch and methodologies to support guidance development on complex generic products including implant\, inhalation\, and topical products\nInnovative methodologies and design recommendations for demonstrating therapeutic equivalence\nCommon regulatory challenges and solutions for generic products with complex drug substances\, excipients\, and formulations\nKnown issues and practical strategies for addressing nitrosamine contamination in pharmaceutical products\n\nLearning Objectives: \n\nStay up-to-date with the latest advancements in science\, research\, guidance development\, and regulatory evaluation related to generic drug products\nRecognize and explain how the FDA’s GDUFA-funded research can be leveraged to support and inform generic drug development\nUtilize various strategies and methodologies to facilitate efficient generic drug development\n\nVisit the event page for more information.
URL:https://about.citiprogram.org/event/advancing-generic-drug-development-translating-science-to-approval-2025/
LOCATION:Online
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20251008T130000
DTEND;TZID=America/New_York:20251008T153000
DTSTAMP:20260405T181556
CREATED:20250926T163541Z
LAST-MODIFIED:20251015T184733Z
UID:59209-1759928400-1759937400@about.citiprogram.org
SUMMARY:FDA WORKSHOP: 10th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop
DESCRIPTION:The FDA Oncology Center of Excellence’s Patient-Focused Drug Development (PFDD) program will host the 10th Annual Clinical Outcome Assessment in Cancer Clinical Trials (COA-CCT) Workshop\, focusing on the use of patient-reported outcome (PRO) measures in oncology trials. This year’s workshop will highlight the finalized 2024 FDA guidance on core PROs and showcase recent examples of how these outcomes are used in oncology product labeling to reflect patient experience. \nMeeting Goals \n\nExamine the integration of patient-generated data into regulatory submissions over the past decade.\nDiscuss research that has advanced the science of analyzing PROs.\nAnalyze historical examples of how core PRO data have been incorporated into labeling for anti-cancer products.\nReview how PRO core outcomes have been utilized in cancer drug development.\nExplore future directions for the analysis and visualization of PRO data.\nIdentify key\, achievable milestones for advancing PRO data science and its regulatory use over the next five years.\n\nVisit the event page for more information.
URL:https://about.citiprogram.org/event/fda-workshop-10th-annual-clinical-outcome-assessment-in-cancer-clinical-trials-workshop/
LOCATION:Online
ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/04/fda-logo.png
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20251008T150000
DTEND;TZID=America/New_York:20251008T160000
DTSTAMP:20260405T181556
CREATED:20250929T155732Z
LAST-MODIFIED:20251015T184728Z
UID:59224-1759935600-1759939200@about.citiprogram.org
SUMMARY:Science Based Non-Academic Careers (SNAC): “How to Leverage Your Scientific Skills to Thrive in Biotech R&D”
DESCRIPTION:The Scientific Networking and Career (SNAC) Workshop is designed to help NCI Fellows\, Staff Scientists\, and Staff Clinicians explore a wide range of science-based career opportunities beyond traditional academic research roles. \nTopics Covered: \n\nWhat positions are available in Biotech R&D? Are there more options than just “wet lab” positions?\nWhat skills translate and are required for Biotech R&D?\nHow do I catch my “big break” in Biotech R&D?\nDoes networking matter?\nHow do I merge “classic science” with “future science”?\n\nVisit the event page for more information.
URL:https://about.citiprogram.org/event/science-based-non-academic-careers-snac-how-to-leverage-your-scientific-skills-to-thrive-in-biotech-rd/
LOCATION:Online
ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/09/nih-logo.png
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