BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//OCRA-DG - Regulatory Affairs - ECPv6.11.2.1//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-ORIGINAL-URL:https://ocra-dg.org
X-WR-CALDESC:Events for OCRA-DG - Regulatory Affairs
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/Los_Angeles
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20240310T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20241103T090000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240522T120000
DTEND;TZID=America/Los_Angeles:20240522T130000
DTSTAMP:20260417T021056
CREATED:20240221T193357Z
LAST-MODIFIED:20240508T052647Z
UID:28020-1716379200-1716382800@ocra-dg.org
SUMMARY:FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance
DESCRIPTION:FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance \nDate: Wednesday\, May 22\, 2024\nTime: 12pm – 1pm PT\nAudience: Medical device quality assurance\, regulatory affairs\, and R&D leaders and practitioners.\nPlatform: Zoom \nIn April 2023 FDA published its Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance. There has been much discussion regarding the scope and implications of the draft guidance\, and FDA has been actively reviewing PCCPs in submission prior to and since the publication of this document. This session will walk through the contents of the draft guidance highlighting specific recommendations\, implications to industry and FDA\, and how this guidance might help or hinder an effective regulatory framework for incorporating AI/ML functionality into medical devices. \nLearning Objectives: \n\nUnderstanding the requirements of FDA’s PCCP for AI/ML draft guidance\nUnderstanding of the implications of PCCPs for AI/ML-enabled product modifications and submissions\nHow the draft guidance may impact FDA’s efforts to establish a regulatory framework for AI/ML-enabled medical devices\n\nRegister now to secure your spot and empower your team for success! \n  \n\n\nAbout the Speaker:\n \nEric Henry\, Sr. Quality Systems & Compliance Advisor at King & Spalding LLP\n \nEric is a Senior Quality Systems and Compliance Advisor in the FDA & Life Sciences Practice of the law firm King & Spalding.  He is a 35-year industry veteran and since 2018 has provided advisory and consulting services focused on regulatory compliance\, enforcement\, and policy matters for industries regulated by the FDA. Eric’s guidance focuses on FDA requirements to professionals in medical device manufacturing\, including but not limited to quality systems requirements\, inspection preparedness and post-market obligations. He also advises corporate management and boards on their responsibilities and expectations of the FDA. \n  \n  \n\n  \nFree to Members\n$20 for Nonmembers \nRegister Now! \nRegister for your team of 5+ participants? Please email programs@ocra-dg.org. \n\n  \nOCRA Gold Sponsors:
URL:https://ocra-dg.org/event/fda-pccp/
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240530T173000
DTEND;TZID=America/Los_Angeles:20240530T193000
DTSTAMP:20260417T021056
CREATED:20240221T193321Z
LAST-MODIFIED:20240521T064851Z
UID:28019-1717090200-1717097400@ocra-dg.org
SUMMARY:IDE Submission Best Practice\, and Pitfalls to Avoid - from Both Regulatory & Clinical Perspectives
DESCRIPTION:IDE Submission Best Practice\, and Pitfalls to Avoid – from Both Regulatory & Clinical Perspectives \nDate: Thursday\, May 30\, 2024 (New Date!)\nTime: 5:30pm – 7:30pm PT\nAudience: Regulatory and clinical affairs professionals in medical device industry\nLocation: Alcon Laboratories\, 20511 Lake Forest Dr\, Lake Forest\, CA 92630 (New Location!) \nThis panel discussion provides an overview of the critical elements for a successful IDE strategy and submission\, focusing on best practices from both regulatory and clinical perspectives. The discussion will focus on case scenarios and pitfalls to avoid\, facilitating the understanding of the content. Attendees will have the opportunity to learn from the discussions and ask questions.\nSubmit your questions after registration and have them answered at the event! \nLearning Objectives: \n\nOverview of IDE submission process\nBest practices of IDE submission and common pitfalls to avoid\nNavigating the review process\nNow you’re approved…what to expect.\n\nAgenda: \n\n17:30   Check in\, light dinner & social networking\n18:00  Introducing OCRA and speakers\n18:10   Panel Presentation and Q&A\n19:10   Open discussion & social networking\, other announcements\n19:30   Adjourn\n\nRegister now to secure your spot and empower your team for success! \n  \n\n\nAbout the Speakers:\n \nMagda Michna\, Ph.D.\, Chief Clinical\, Regulatory and Medical Affairs Officer at STAAR Surgical Company\n \nDr. Michna brings extensive expertise in global clinical\, regulatory\, and medical affairs. Previously\, she held key leadership roles at AcuFocus Inc. (a subsidiary of Bausch & Lomb)\, Presbia LLC\, and within Alcon’s surgical franchise. With a focus on accelerating market entry and driving adoption\, Dr. Michna has spearheaded the development of premium intraocular lens and surgical device technologies. Her strategic leadership and deep understanding of regulatory landscapes have facilitated successful market introductions. \n  \nLaura Schall\, Director\, Clinical Affairs at STAAR Surgical Company\n \nLaura Schall brings extensive experience in clinical research that spans the sponsor and clinical investigator perspectives. Laura started her research career as a Clinical Research Coordinator at a private medical practice\, where she was responsible for the execution of clinical studies. Laura transitioned to the sponsor side\, first as part of a Clinical Research Organization (CRO) before she made the leap into industry\, where she has led the strategy and execution of multiple registration and post-market clinical trials. Laura’s extensive knowledge of clinical research has led to multiple successful product registrations. \n  \n\n  \n\n\nIn-Person Ticket\n$20 for Member\n$35 for Nonmember \nLight fare & beverage provided at 5:30pm PST. \nRegister Now! \n\n\nVirtual Ticket\nFREE for Member\n$20 for Nonmember \nEvent starts at 6pm PST. \nRegister Now! \n\n\nRegister for your team of 5+ participants? Please email programs@ocra-dg.org. \n\n  \nThank you to our Sponsors!\n  \n  \n  \n  \n  \n  \n             
URL:https://ocra-dg.org/event/ide-submission-best-practice-and-pitfalls-to-avoid-from-both-regulatory-clinical-perspectives/
LOCATION:Alcon Laboratories\, 20511 Lake Forest Dr\, Lake Forest\, CA\, 92630
CATEGORIES:Events,In Person
END:VEVENT
END:VCALENDAR