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DTSTART;TZID=America/New_York:20251211T090000
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UID:59821-1765443600-1765449000@about.citiprogram.org
SUMMARY:Quality and Regulatory Predictability: Shaping USP Standards
DESCRIPTION:This session will explore how USP public standards enhance drug quality\, simplify product development\, facilitate regulatory compliance\, and promote greater predictability in regulatory outcomes. Participants will also gain an understanding of how USP standards are created and discover opportunities to contribute\, either as sponsors or through public comments\, to the development of upcoming standards. \nTopics Covered \n\nFDA’s responsibility in USP standards development\nValue/role of USP monographs for FDA\nUnderstanding how the use of standards – and demonstrated compliance – factor into FDA’s regulatory activities\nIndustry’s position in USP standards development\nManufacturers’ part in the establishment of USP standards\nOverview of USP standards in regulatory framework\nDiscussion of the USP revision process\nHow to get involved in monograph development\n\nVisit the event page for more information.
URL:https://about.citiprogram.org/event/quality-and-regulatory-predictability-shaping-usp-standards/
LOCATION:Online
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DTSTART;TZID=America/New_York:20251211T140000
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UID:59828-1765461600-1765465200@about.citiprogram.org
SUMMARY:Free Live Webinar - Ethical Research Relationships: IRBs and Focus Groups
DESCRIPTION:Ethical Research Relationships: IRBs and Focus Groups\nThursday\, December 11\, 2025 at 2:00 p.m. ET\nFocus groups primarily facilitate open-ended dives within qualitative research\, often asking participants to share personal stories\, experiences\, or perspectives in a group setting. We’ll explore human subjects protections and other considerations at the core of ethical research relationships related to focus groups\, including when\, why\, and how to engage with Institutional and Tribal Research Review Boards (IRBs and Tribal IRBs)\, and best practices for informed consent and confidentiality with special attention to working with Indigenous communities. \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-ethical-research-relationships-irbs-and-focus-groups/
LOCATION:Online
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