BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Global Biodefense - ECPv6.18.3//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-ORIGINAL-URL:https://globalbiodefense.com
X-WR-CALDESC:Events for Global Biodefense
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:20210314T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20211107T060000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20220313T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20221106T060000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20230312T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20231105T060000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221005
DTEND;VALUE=DATE:20221006
DTSTAMP:20220922T145702Z
CREATED:20220922T145702Z
LAST-MODIFIED:20220922T145702Z
UID:56457-1664928000-1665014399@globalbiodefense.com
SUMMARY:Study Data Standards Update for FDA CBER
DESCRIPTION:FDA’s Center for Biologics Evaluation and Research (CBER)  will host a free virtual format workshop on 5 October 2022 entitled Study Data Standards Update for CBER: Your Guide to a Successful Submission. \nCBER will discuss CBER’s support and requirement starting March 15\, 2023 for the Standard for the Exchange of Nonclinical Data (SEND) \, which was published in the Federal Register on July 14\, 2020\, and the addition of SEND for CBER to the FDA Data Standards Catalog. \nFDA will discuss the brief background of the new requirement and how SEND will aid CBER reviewers. The webinar will also address common issues in submission data. \nINTENDED AUDIENCE\n\nRegulatory science and regulatory affairs professionals working on clinical and non-clinical data submissions for BLAs/NDAs/ANDAs/INDs to CBER\nConsultants focused on clinical and non-clinical data submission\nHealthcare professionals specializing in clinical and non-clinical data\nForeign regulators\n\nFDA RESOURCES\n\nFederal Register Notice regarding SEND for CBER\nFDA Data Standards Catalog\nStudy Data Technical Conformance Guide\nFDA Study Data Standards Resources\nEmail: cber-edata@fda.hhs.gov\n\nPlease visit FDA’s Study Data Standards Update for CBER: Your Guide to a Successful Submission meeting webpage for more information.
URL:https://globalbiodefense.com/event/study-data-standards-update-for-fda-cber/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221011T090000
DTEND;TZID=America/New_York:20221011T120000
DTSTAMP:20220923T194931Z
CREATED:20220923T194822Z
LAST-MODIFIED:20220923T194931Z
UID:56491-1665478800-1665489600@globalbiodefense.com
SUMMARY:Epidemics That Didn't Happen
DESCRIPTION:Join Resolve to Save Lives for a dynamic conversation to mark the release of the second edition of “Epidemics that Didn’t Happen.” This virtual event and new report will illustrate how global and local investments in preparedness\, combined with swift\, strategic responses by public health authorities\, can transform the trajectory of outbreaks\, saving lives and preventing suffering. \nThe latest “Epidemics that Didn’t Happen” report celebrates successful outbreak responses from around the world that demonstrate the returns—in lives saved—of investing in preparedness and response systems. These examples—from Brazil\, Burkina Faso\, Democratic Republic of Congo\, Guinea\, Indonesia\, India and Tanzania—are a testament to the power of preparedness and a roadmap for future success in preventing epidemics. \nCOVID-19 and recent outbreaks of monkeypox and polio have highlighted how vulnerable the world is to infectious diseases. But every day\, public health workers stop epidemics before they start.\nJoin Resolve to Save Lives for a dynamic conversation to mark the release of the second edition of “Epidemics that Didn’t Happen.” This virtual event and new report will illustrate how global and local investments in preparedness\, combined with swift\, strategic responses by public health authorities\, can transform the trajectory of outbreaks\, saving lives and preventing suffering. \n\nWelcome & Opening Remarks – Dr. Tom Frieden\, President and CEO\, Resolve to Save Lives\nKeynote: Reforming Global Health for the Next Pandemic – Precious Matsoso\, former director-general of South Africa’s Department of Health and former chair of the World Health Organization’s Executive Board\nSnapshot of Epidemics that Didn’t Happen\, 2022 – Amanda McClelland\, SVP\, Resolve to Save Lives\nPanel Discussion: Lessons Learned from Successful Outbreak Responses – Featuring: Márcio Garcia\, Health Surveillance Superintendent\, Rio de Janeiro Municipal Health Secretariat ; Representative from Indonesian Red Cross Society (invited)\n\nPlease visit the Resolve to Save Lives’ Epidemics That Didn’t Happen event site for more information.
URL:https://globalbiodefense.com/event/epidemics-that-didnt-happen/
CATEGORIES:Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221024T110000
DTEND;TZID=America/New_York:20221024T172000
DTSTAMP:20220905T180114Z
CREATED:20220905T180114Z
LAST-MODIFIED:20220905T180114Z
UID:56285-1666609200-1666632000@globalbiodefense.com
SUMMARY:Board of Scientific Counselors\, National Center for Health Statistics
DESCRIPTION:The CDC has announced the Board of Scientific Counselors\, National Center for Health Statistics (BSC\, NCHS) will convene 24 October 2022 in a live broadcast public meeting. \nThe Board is charged with providing advice and making recommendations to the Secretary\, Department of Health and Human Services; the Director\, CDC; and the Director\, NCHS\, regarding the scientific and technical program goals and objectives\, strategies\, and priorities of NCHS. \nThe meeting agenda will include a Center update by the NCHS Director in addition to updates on NCHS data collection\, analysis\, and reporting activities\, including upcoming changes to the National Hospital Ambulatory Medical Care Survey (NHAMCS); status of a National Ambulatory Medical Care Survey (NAMCS) pilot and plans for obtaining clinician visit data; a new project to improve metadata and catalogs for the public to access restricted use data files; and new releases of linked data sets. The Board’s Workgroup to Consider and Assess Measures of Discrimination for Use in NCHS Surveys will brief the Board with findings from 6 months of information-gathering and assessment work. The Committee will reserve time for public comment at the end of the day. Meeting times and topics are subject to change as priorities dictate. \nMeeting Information: Please visit the BSC\, NCHS website for details. Further information and the meeting agenda will be available on the BSC website\, including instructions for accessing the live meeting broadcast.
URL:https://globalbiodefense.com/event/board-of-scientific-counselors-national-center-for-health-statistics/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221026T140000
DTEND;TZID=America/New_York:20221026T150000
DTSTAMP:20221007T143637Z
CREATED:20221007T143454Z
LAST-MODIFIED:20221007T143637Z
UID:56536-1666792800-1666796400@globalbiodefense.com
SUMMARY:Responding to the Climate Change and Health Crisis: A Framework for Academic Public Health
DESCRIPTION:The Association of Schools and Programs of Public Health (ASPPH) will host a framework launch webinar on Responding to the Climate Change and Health Crisis from 2:00 – 3:00 PM ET on Wednesday\, October 26\, featuring an expert panel that will discuss some of the challenges and opportunities it identifies. \nThe framework examines climate change and health in four primary domains – Education and Training\, Research\, Practice\, and Policy and Advocacy – and considers three cross-cutting themes: Environmental Justice\, Social Justice\, and Health Equity; Interprofessional and Interdisciplinary Collaborations; and Partnerships for Impact. The framework concludes with a set of evidence-based principles and recommendations – for both schools and programs of public health (SPPH) and ASPPH as a whole – to take collective action and work with vested partners to reduce the impacts of climate change on population health. \nThe framework was developed by the ASPPH Task Force on Climate Change and Health\, comprised of experts in a range of climate change and health-related topics from across our member schools and programs\, with feedback from members and partners. In conjunction\, we are also releasing ASPPH’s statement of commitment to addressing climate change and health. \nPlease visit ASPPH for more information.
URL:https://globalbiodefense.com/event/responding-to-the-climate-change-and-health-crisis-framework-for-academic-public-health/
CATEGORIES:Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221027
DTEND;VALUE=DATE:20221029
DTSTAMP:20220921T222128Z
CREATED:20220921T222128Z
LAST-MODIFIED:20220921T222128Z
UID:56444-1666828800-1667001599@globalbiodefense.com
SUMMARY:Best Practices: Modeling Approaches to Support Generic Product Development
DESCRIPTION:FDA and the Center for Research on Complex Generics (CRCG) will host a free public workshop on October 27-28\, 2022: Best Practices for Utilizing Modeling Approaches to Support Generic Product Development \nThe purpose of this two-day workshop is to discuss and illustrate how generic product developers can utilize modeling approaches in conjunction with in vitro data and other knowledge to support the development of complex generics that may otherwise rely upon challenging in vivo studies to demonstrate bioequivalence. \nThis workshop will engage experts from regulatory agencies\, the generic drug industry\, consultants\, academia\, and others in the field of modeling and simulation to discuss the opportunities and best practices for incorporating modeling and simulation approaches into generic drug development programs and regulatory submissions. The workshop will also identify commonalities in methodologies/workflows or in silico models supporting alternative BE approaches and clarify how a model master file may be leveraged to advance drug product development\, facilitate regulatory assessment\, and streamline drug product approval. \nFDA and the CRCG—which is a collaboration between the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy—are dedicated to advancing programs that stimulate scientific dialogue\, disseminate current insights about complex generics\, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines. \nHighlighted topics include: \n\nUse of model integrated evidence to support demonstrations of BE in a regulatory context\nUse of the same or similar model or modeling strategy across multiple submissions related to complex drug products\nMechanistic modeling approaches supporting BE assessments for oral drug products\nApplications of quantitative comparative approaches to support the development of complex generic drug products\nCase examples supporting the recently introduced concept of “model master files”\n\nPlease visit the FDA’s Best Practices for Utilizing Modeling Approaches to Support Generic Product Development meeting page for information on registration.
URL:https://globalbiodefense.com/event/best-practices-modeling-approaches-to-support-generic-product-development/
CATEGORIES:Government Hosted,Webinar-Webcast
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/09/complex-genomics-modeling-approaches-generic-product-fda.jpg
LOCATION:https://umaryland.zoom.us/webinar/register/WN_QLkZn5TbTYqu4F986aKD6g
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221027T140000
DTEND;TZID=America/New_York:20221027T150000
DTSTAMP:20221025T173153Z
CREATED:20221025T173153Z
LAST-MODIFIED:20221025T173153Z
UID:56589-1666879200-1666882800@globalbiodefense.com
SUMMARY:Public Health Workforce Calculator: Staffing up to Achieve Foundational Services
DESCRIPTION:In 2021\, an analysis of the public health workforce found that state and local governmental public health departments need an 80% increase in their workforce to provide a minimum set of public health services to the nation. In response to this gap\, the Public Health National Center for Innovations at PHAB\, de Beaumont Foundation\, and the Centers for Disease Control and Prevention’s Center for State\, Tribal\, Local and Territorial Support developed the Public Health Workforce Calculator to aid local health departments in estimating staffing needs to provide the Foundational Public Health Services in their community. Join us on October 27th at 2PM ET to learn more about the Calculator and how it can contribute to workforce staffing needs and planning for public health funding. \nWebinar Objectives\n– Describe how the analysis was used to successfully build support for health departments\n– Explain the intended use of the recently released Public Health Workforce Calculator.\n– Demonstrate how to use the Calculator\, including identifying the Calculator’s best use cases.
URL:https://globalbiodefense.com/event/public-health-workforce-calculator-staffing-up-to-achieve-foundational-services/
CATEGORIES:Conference,Webinar-Webcast
LOCATION:https://us02web.zoom.us/webinar/register/1316650817717/WN_273HybPhTfOA1Df_brsQNQ
END:VEVENT
END:VCALENDAR