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X-WR-CALDESC:Events for Global Biodefense
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DTSTART;VALUE=DATE:20221011
DTEND;VALUE=DATE:20221012
DTSTAMP:20220921T200930Z
CREATED:20220921T200613Z
LAST-MODIFIED:20220921T200930Z
UID:56431-1665446400-1665532799@globalbiodefense.com
SUMMARY:FDA NanoDay Symposium 2022
DESCRIPTION:The FDA NanoDay Symposium 2022 will be held on 11 October 2022. The event will address drug development of products that contain nanomaterials in their formulation and how the newly finalized guidance to industry for products that contain nanomaterials can be implemented in filings to the FDA. \nHighlighted topic areas include: \n\nPrimary Chemistry Manufacturing and Controls (CMC) and nonclinical hurdles for developing products that contain nanomaterials\nDevelopment and Characterization of Generic Drug Products Containing Nanomaterials\nConsiderations for the Quality\, Safety and Efficacy of Prophylactic Lipid Nanoparticle mRNA Vaccines\nCase studies on the development of the COVID mRNA lipid nanoparticle vaccine products\nFuture of Continuous Manufacturing of Drug Products Containing Nanomaterials\nEfforts to establish standards and standard methods for monitoring products that contain nanomaterials\nA contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products\nA nonclinical perspective of developmental challenges of products that contain nanomaterials\nSafety Evaluation of Food Contact Substances Containing Nanomaterials\n\nThe intended audience includes: Regulatory science and regulatory affairs professionals working on drug products\, including biologicals\, that contain nanomaterials and submit IND/NDA/BLA/ANDA applications for FDA review; researchers working on applications of nanotechnology for pharmaceutical products\, analytical methodology for control of pharmaceuticals that contain nanomaterials\, and nonclinical studies to support human clinical trials; and foreign regulators who review comparable pharmaceutical products that contain nanomaterials. \nPlease visit the FDA’s NanoDay Symposium 2022 website for more information. \nFDA RESOURCES\n\nGUIDANCE DOCUMENT: Drug Products\, Including Biological Products\, that Contain Nanomaterials – Guidance for Industry; APRIL 2022\nGUIDANCE DOCUMENT: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology – Guidance for Industry; JUNE 2014\nGUIDANCE DOCUMENT: Liposome Drug Products: Chemistry\, Manufacturing\, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; APRIL 2018\nGUIDANCE DOCUMENT: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs\, Including Well-Characterized\, Therapeutic\, Biotechnology-derived Products – Guidance for Industry; NOVEMBER 1995
URL:https://globalbiodefense.com/event/fda-nanoday-symposium-2022/
CATEGORIES:Continuing Education,Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221006T083000
DTEND;TZID=America/New_York:20221006T130000
DTSTAMP:20220921T202014Z
CREATED:20220921T201913Z
LAST-MODIFIED:20220921T202014Z
UID:56435-1665045000-1665061200@globalbiodefense.com
SUMMARY:VRBPAC Meeting - Vaccine Strain Selection 2023 Southern Hemisphere Flu Season
DESCRIPTION:The FDA Vaccines and Related Biological Products Advisory Committee will convene on 6 October 2022 in open session to discuss the Strain Selection for the Influenza Virus Vaccines for the 2023 Southern Hemisphere Influenza Season. \nMaterials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page. Interested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. The Docket Number is FDA-2022-N-1745 \nPlease visit the FDA VRBPAC Meeting website for more information.
URL:https://globalbiodefense.com/event/vrbpac-meeting-vaccine-strain-selection-2023-southern-hemisphere-flu-season/
CATEGORIES:Government Hosted
LOCATION:https://youtu.be/qazitJMHZK4
END:VEVENT
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:20220929T110000
DTEND;TZID=America/New_York:20220929T150000
DTSTAMP:20220924T161732Z
CREATED:20220924T161603Z
LAST-MODIFIED:20220924T161732Z
UID:56507-1664449200-1664463600@globalbiodefense.com
SUMMARY:National Biodefense Science Board Public Meeting
DESCRIPTION:The next public meeting of the National Biodefense Science Board (NBSB) will take place on Thursday\, September 29. \nJoin NBSB members\, distinguished guests\, federal leaders\, and subject matter experts exploring topics such as how best to support rural and underserved communities during the COVID-19 pandemic\, use of virtual healthcare during disasters\, and health system operational data considerations during a health emergency. For additional details and meeting agenda topics\, please see the NBSB Public Meeting page. An agenda for the meeting is posted on the website. \nHighlighted agenda items include: \n\nReadiness and Resilience Working Group Readout\nCountermeasures and Operational Research Working Group Readout\nDisaster and Public Health Emergency Training Needs\, Challenges\, and Opportunities for the Health Workforce in the United States\nOpen Discussion – Additional Key Biodefense Lessons from COVID-19\n\nAdvanced registration is required. To register for the meeting and for additional information\, visit the NBSB Public Meeting page. \nRegister to Address the NBSB\nThe NBSB are inviting people with expertise or experience related to the collection\, analysis\, and operational use of health data to improve access to and resilience of virtual health care to address the Board and/or experience and expertise addressing rural and underserved communities during the COVID-19 pandemic. \nWe are particularly interested in hearing stakeholder input related to the following topics: \nOperational Health Data for Disaster Response\n\nWhat are your concerns about the confidentiality of your health data or how it might be used?\nWhat are your concerns with the current HHS data reporting requirements for health systems\, including the format\, timing\, and extent of data that must be submitted?\nShould data reporting requirements\, or modified requirements\, be continued after the COVID-19 reporting stops?\nWhat are the current training needs for healthcare staff to meet the requirements for collection and reporting of health data?\nWhat is the level of effort (i.e. staffing and person-time) required to satisfy all of the current health system reporting requirements?\nIf your health care or public health organization has agreements in place to share information among regional partners\, do you have processes in place to improve data sharing during a disaster? Has data sharing during disasters led to an improved disaster response?\nIf your health care or public health organization has agreements in place to share information among regional partners\, do you have any special measures in place to ensure that rural and underserved communities are represented?\n\nVirtual Healthcare for Disaster Response\n\nWhat could be done to improve the reliability and availability of internet access and the appropriate computers or software? If available\, is the use of telephone or radio an acceptable option for medical care during a disaster?\nWhat are your concerns about the continuity of care\, including the availability of your own medical history and proper recording of virtual care?\nAre there adequate resources in place to ensure that you receive the medications you need during a disaster?\nWould you be willing to have a “family visit” for healthcare\, where multiple people are treated on the same virtual visit?\n\nUpdate: NBSB currently has as many public speakers as can accommodated in the time available\, so please send written comments on related topics to NBSB@hhs.gov\, which will be shared with the board members ahead of the meeting. Additional meeting materials will be made available to the public on the NBSB Public Meeting page.
URL:https://globalbiodefense.com/event/national-biodefense-science-board-public-meeting-4/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220928
DTEND;VALUE=DATE:20220930
DTSTAMP:20240623T193106Z
CREATED:20220921T190315Z
LAST-MODIFIED:20240623T193106Z
UID:56428-1664323200-1664495999@globalbiodefense.com
SUMMARY:GBHI 2022 - 5th Annual Global Bioequivalence Harmonization Initiative Meeting
DESCRIPTION:The goal of the Global Bioequivalence Harmonization Initiative (GBHI) conference is to offer the most informative and up to date science and regulation of bioequivalence in global drug development.  \nThe FDA AAPS EUFEPS 5th Annual GBHI Meeting will be held 28-29 September 2022. GBHI workshop provides an open forum for pharmaceutical scientists from academia\, industry and regulatory agencies to discuss various bioequivalence topics at issue including: \n\nFed vs fasted studies for immediate release dosage forms\nRelevance of excipients\, disintegration/dissolution specificities\, drug substance properties and physiological GI conditions\nReplicate design for BE of Highly Variable Drugs\ntwo-stage design and Pharmacokinetic modelling as supportive tools for BE assessment\nScientifically-based approaches for a waiver of clinical endpoint trials\nStudy design and acceptance criteria\n\nThis conference is intended for leaders in Academia\, the Pharmaceutical and Biotechnology Industry (PhRMA\, BIO\, GPhA)\, contract research organizations\, API manufacturers\, and domestic and international regulatory agencies in positions to affect the science and regulation of drug discovery and development\, who wish to stay abreast of the national and international initiatives affecting the development of safe and effective pharmaceutical drug products. \nPlease visit the FDA’s Global Bioequivalence Harmonization Initiative (GBHI) conference website for more information.
URL:https://globalbiodefense.com/event/gbhi-2022-5th-annual-global-bioequivalence-harmonization-initiative-meeting/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220926T103000
DTEND;TZID=America/New_York:20220926T173000
DTSTAMP:20220907T151745Z
CREATED:20220907T151724Z
LAST-MODIFIED:20220907T151745Z
UID:56350-1664188200-1664213400@globalbiodefense.com
SUMMARY:IARPA PICARD Program Proposers' Day
DESCRIPTION:The IARPA Pursuing Intelligent Complex Aerosols for Rapid Detection (PICARD) program will host a Proposer’s Day on 26 September 2022 to introduce the PICARD program to potential proposers and to provide information on technical requirements and program objectives. The PICARD program intends to develop a fieldable sensing platform for the rapid identification of aerosol particles in plumes. This platform will address both point detection (in situ) and standoff detection capabilities that focus on the complexity of aerosols with non-uniform sizes\, structures\, and chemical composition as well as dispersion in challenging environments. \nThe goal of PICARD is to develop novel integrated hardware and software tools that will improve the current state of the art with respect to chemical specificity\, accuracy\, and sensitivity. \nThe PICARD Proposers’ Day is a hybrid event that will be broadcast via the Webex video conference platform for remote attendees. In person participation is encouraged to facilitate information exchange and team forming. For planning purposes\, the venue is located near the Ballston Metro Station in Arlington\, VA. A recorded video of the meeting will be made available to the public on the IARPA website after the event. \nProposers’ Day Registration Closes: Friday\, September 16\, 2022 at noon EDT. Please visit IARPA’s PICARD Proposers’ Day website for more information. \n 
URL:https://globalbiodefense.com/event/iarpa-picard-program-proposers-day/
LOCATION:Ballston Metro Station\, Arlington\, VA\, United States
CATEGORIES:Government Hosted
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/09/iarpa-picard-intelligent-complex-aerosol-rapid-detection.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220926
DTEND;VALUE=DATE:20220928
DTSTAMP:20220921T174333Z
CREATED:20220921T174333Z
LAST-MODIFIED:20220921T174333Z
UID:56420-1664150400-1664323199@globalbiodefense.com
SUMMARY:MAQC 2022 - Massive Analysis and Quality Control Society Conference
DESCRIPTION:The 5th Annual Meeting of the FDA/National Center for Toxicological Research (NCTR) – Massive Analysis and Quality Control Society (MAQC) 2022 Conference will be held September 26-27\, 2022\, at the U.S. FDA Headquarters\, White Oak Campus in Silver Spring MD. \nConference presentations\, abstracts\, and discussions will include themes around: Explainable/Reproducible AI/ML\, AI/ML in health-related datasets\, SARS-CoV-2 and public health\, Single-cell\, genomics\, image analysis\, reference samples\, reproducible science and more. \nHighlighted topics and presentations include: \n\nDARPA’s explainable AI (XAI) program: A retrospective\nDrug repurposing for COVID-19 using explainable machine learning and mechanistic models of signal transduction circuits related to SARS-CoV-2 infection with real world data validation\nAn automated bioinformatic software testing and benchmarking platform to standardize the development of accurate\, reproducible\, and scalable omics analysis tools\nLeaSH: a High-Throughput COVID-19 Test to Profile Viral and Host Transcriptomes by Next Generation\nSequencing\nSome non-obvious factors that enhance or diminish observed and theoretical Illumina library complexity\nAI or Animal – A reproducibility perspective\nReproducible AI for supporting regulatory applications – a case study\nImproving preclinical pathology analysis with PathologAI\nExplainable approach for species identification using LIME\nEvaluation of mutagenic susceptibility of different stages in germ cell development of Caenorhabditis elegans using next generation sequencing\nIntegrated Calling and Evaluation of Gene Fusion Detection by Targeted RNA Sequencing of Reference Samples with Long and Short Reads\nMutual genome and transcriptome enrichment and sequencing in single cells with ResolveOME amplification chemistry to illuminate complex biological mechanisms\n\nPlease visit the Massive Analysis and Quality Control Society (MAQC) 2022 Conference website for more information and to register.
URL:https://globalbiodefense.com/event/maqc-2022-massive-analysis-and-quality-control-society-conference/
LOCATION:FDA White Oak Campus\, 10903 New Hampshire Ave\, Silver Spring\, MD\, 20993\, United States
CATEGORIES:Government Hosted,Webinar-Webcast
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220922T143000
DTEND;TZID=America/New_York:20220922T153000
DTSTAMP:20220921T203623Z
CREATED:20220921T203623Z
LAST-MODIFIED:20220921T203623Z
UID:56437-1663857000-1663860600@globalbiodefense.com
SUMMARY:Navigating Avian Influenza: From Prevention to Recovery
DESCRIPTION:Hear insights and information from APHIS and other experts on steps to take and what to expect during a bird flu outbreak during a free webinar on 22 September 2022. \nLearn from USDA and other experts about how to keep your flocks safe from highly pathogenic avian influenza (HPAI). This session is for enthusiasts\, farmers\, educators\, and anyone interested in signs and symptoms of HPAI\, what to watch out for during fall migration\, and how to develop an effective biosecurity and response plan. Hear about one educational farm’s experience managing a potential HPAI outbreak and get tips on how to keep your poultry flocks safe. \nPlease register for the Navigating Avian Influenza webinar in advance.
URL:https://globalbiodefense.com/event/navigating-avian-influenza-from-prevention-to-recovery/
CATEGORIES:Government Hosted
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/09/navigating-avian-influenza-usda.jpg
LOCATION:https://us02web.zoom.us/webinar/register/WN_z8GAVnu2SkiAfdqfMXgK0g
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220922T083000
DTEND;TZID=America/New_York:20220922T170000
DTSTAMP:20220921T183353Z
CREATED:20220921T183322Z
LAST-MODIFIED:20220921T183353Z
UID:56423-1663835400-1663866000@globalbiodefense.com
SUMMARY:VRBPAC Meeting - Rebiotix Indication for Recurrent Clostridioides difficile Infection
DESCRIPTION:The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will convene on 22 September 2022 to discuss the Biologics License Application # 125739 (BLA – 125739) from Rebiotix Inc. for a product\, Rebyota (Fecal Microbiota\, Live)\, with a requested indication to “reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent Clostridioides difficile infection.” \nFDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting\, any background material will be made publicly available at the time of the advisory committee meeting\, and additional materials will be posted on FDA’s website after the meeting. \nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. \nThe Docket Number is FDA-2022-N-1608.
URL:https://globalbiodefense.com/event/vrbpac-meeting-rebiotix-indication-for-recurrent-clostridioides-difficile-infection/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:https://www.youtube.com/watch?v=vrahKrbyJaU
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220921T120000
DTEND;TZID=America/New_York:20220921T130000
DTSTAMP:20220921T172921Z
CREATED:20220921T172727Z
LAST-MODIFIED:20220921T172921Z
UID:56416-1663761600-1663765200@globalbiodefense.com
SUMMARY:Virtual Town Hall Series - Monkeypox Test Development and Validation
DESCRIPTION:The U.S. Food and Drug Administration (FDA) will host a virtual town hall for monkeypox test developers on 21 September 2022. The purpose of these town halls is to help answer technical questions about the development and validation of tests for monkeypox. \nThe FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases\, including monkeypox . The FDA is committed to providing timely guidance to support response efforts to this public health emergency. \nThe guidance\, Policy for Monkeypox Tests to Address the Public Health Emergency\, includes policies specific to this public health emergency. \nThe FDA hosted a webinar on September 14\, 2022\, to discuss highlights of and answer questions about the final guidance. The presentation\, printable slides\, and transcript from that webinar are available at CDRH Learn under “Specialty Technical Topics”\, sub-section “Public Health Emergencies.”
URL:https://globalbiodefense.com/event/virtual-town-hall-series-monkeypox-test-development-and-validation/
CATEGORIES:Conference,Government Hosted
LOCATION:https://fda.zoomgov.com/j/1612083563?pwd=NklWOE1jUlU2dUVlNWtvQTNkdTM5UT09#success
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220921
DTEND;VALUE=DATE:20220923
DTSTAMP:20220420T212311Z
CREATED:20220420T212042Z
LAST-MODIFIED:20220420T212311Z
UID:54799-1663718400-1663891199@globalbiodefense.com
SUMMARY:Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) Meeting
DESCRIPTION:The Scientific Advisory Committee on Alternative Toxicological Methods will meet 21-22 September 2022. \nThis is a Save-the-Date posting. Further details will be made available at the National Toxicology Program website closer to the meeting date.
URL:https://globalbiodefense.com/event/scientific-advisory-committee-on-alternative-toxicological-methods-sacatm-meeting/
CATEGORIES:Conference,Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220912
DTEND;VALUE=DATE:20220914
DTSTAMP:20220830T001753Z
CREATED:20220830T001521Z
LAST-MODIFIED:20220830T001753Z
UID:56267-1662940800-1663113599@globalbiodefense.com
SUMMARY:Presidential Advisory Council on Combating Antibiotic Resistant Bacteria
DESCRIPTION:The 21st Presidential Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB) public meeting is tentatively being planned as an in-person event on September 12 and September 13\, 2022. The meeting will focus on pandemic preparedness and AMR policy. \nHighlighted topics include: \n\nUnderstanding the Human Diagnostic Communication Network (Labs\, Public Health Departments\, and Providers)\nInfection Prevention and Control for Resistant Pathogens during a Medical Surge\nLeveraging the Existing Pipeline of Available Vaccines and Therapeutics while Developing New AMR MCMs (Human)\nDeveloping New Human Diagnostics in an Emergency Situation: What’s Expected\, Needed\, and How We Get What We Need\nA Pandemic Response from a Global Perspective\nThe Agricultural Workforce: Human Health Risk and the Role of Workers as Vectors of Transmission\nThe Role of Associations in Pandemic Response and Dissemination of Information\nImpact of a Public Health Emergency on Human Antibiotic Stewardship Practices\nDiagnosing Fungal Infections and Resistance with our Current Diagnostic Capacity\nThe Role of Diagnostics in Herds: Availability\, Challenges\, and How They’re Used\nThe Federal Strategy for Animal Surveillance\, Information Sharing\, and Disseminating Guidance\nRecognizing the Pandemic: Identifying the “AMR Pandemic” within the Pandemic and Disseminating Information and Guidance\nLeveraging Current Human Antibiotic-Use-Monitoring for AMR Pandemic Surveillance\nRecognizing the Pandemic: Producer Surveillance Methods and Identifying Secondary AMR infections in Animal Production\nDevelopment of New Animal Vaccines and Understanding Federal Regulations\nUnderstanding the Animal Diagnostic Communication Network (Labs\, Producers\, and Veterinarians)\nSources of Environmental Contamination and the Potential for Surveillance\n\nThis meeting is open to the public. Members of the public can choose to attend in-person (attendance will be limited) or view the meeting via webcast. Please visit the HHS 21st Presidential Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB) website to register.
URL:https://globalbiodefense.com/event/paccarb-public-meeting-presidential-advisory-council-on-combating-antibiotic-resistant-bacteria/
LOCATION:Tysons Corner Marriott\, 8028 Leesburg Pike\, Tysons Corner\, VA\, 22182-2719\, United States
CATEGORIES:Conference,Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220830T083000
DTEND;TZID=America/New_York:20220830T170000
DTSTAMP:20240623T192753Z
CREATED:20220829T230154Z
LAST-MODIFIED:20240623T192753Z
UID:56260-1661848200-1661878800@globalbiodefense.com
SUMMARY:Drug Development Considerations for the Prevention of Healthcare Associated Infections
DESCRIPTION:The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are co-sponsoring this public virtual workshop on August 30\, 2022. All meeting materials—including agenda\, panelist affiliations/disclosures\, speaker slides\, workshop recording\, and transcript—will be posted here shortly before and/or after the completion of the workshop. \n\nThe current state of development of pathogen-directed products used to prevent healthcare-associated infections (HAIs).\nEvidence supporting decolonization and pathogen reduction (in colonized patients) as a strategy to prevent infection and transmission of antimicrobial-resistant healthcare-associated pathogens.\nAntimicrobial resistance threats as potential targets for decolonization and pathogen reduction.\nChallenges and potential approaches to drug development and registration of products for the prevention of healthcare-associated infections.\n\nThis meeting will be held in virtual format only. Registration is required for online attendance and will be available until 12 p.m. EDT on August 29\, 2022.
URL:https://globalbiodefense.com/event/drug-development-considerations-for-the-prevention-of-healthcare-associated-infections/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220629T120000
DTEND;TZID=America/New_York:20220629T170000
DTSTAMP:20220622T153805Z
CREATED:20220622T153805Z
LAST-MODIFIED:20220622T153805Z
UID:55703-1656504000-1656522000@globalbiodefense.com
SUMMARY:USG Policies for the Oversight of Life Sciences Dual Use Research of Concern
DESCRIPTION:The purpose of this meeting is to gather feedback from stakeholders about their experiences implementing these policies\, the effect of these policies in terms of achieving their stated goals\, the overarching definition of DURC\, and possible alternative approaches for the oversight and responsible conduct of DURC. \nThis feedback will also be used to inform the discussions of the National Science Advisory Board for Biosecurity (NSABB) in fulfillment their current charge to evaluate and analyze the DURC policies. \nRegistration is not required to view the webcast. \nREAD MORE: Dual Use Research of Concern: NIH to Host Stakeholder Engagement Meeting on Oversight Policies
URL:https://globalbiodefense.com/event/usg-policies-for-the-oversight-of-life-sciences-dual-use-research-of-concern/
CATEGORIES:Conference,Government Hosted
LOCATION:https://osp.od.nih.gov/event/virtual-stakeholder-engagement-meeting-on-usg-policies/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220628T083000
DTEND;TZID=America/New_York:20220628T170000
DTSTAMP:20220527T213139Z
CREATED:20220527T213139Z
LAST-MODIFIED:20220527T213139Z
UID:55118-1656405000-1656435600@globalbiodefense.com
SUMMARY:VRBPAC Meeting on COVID-19 Vaccine Strain Composition Decisions
DESCRIPTION:The VRBPAC will meet in open session on 28 June 2022 to discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified. \nFDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting\, any background material will be made publicly available at the time of the advisory committee meeting\, and additional materials will be posted on FDA’s website after the meeting. \nMaterials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page. \nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. \nThe Docket Number is FDA-2022-N-0905
URL:https://globalbiodefense.com/event/vrbpac-meeting-on-covid-19-vaccine-strain-composition-decisions/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:https://www.youtube.com/watch?v=BFdzNUus_CE
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220615T083000
DTEND;TZID=America/New_York:20220615T170000
DTSTAMP:20220527T210409Z
CREATED:20220527T210409Z
LAST-MODIFIED:20220527T210409Z
UID:55115-1655281800-1655312400@globalbiodefense.com
SUMMARY:VRBPAC Meeting to Review Pediatric (Infant - 5 Years) mRNA Vaccines
DESCRIPTION:The VRBPAC will meet in open session to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age\, and also to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age. \nFDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its website prior to the meeting\, any background material will be made publicly available at the time of the advisory committee meeting\, and additional materials will be posted on FDA’s website after the meeting. \nMaterials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page. \nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. The Docket Number is FDA-2022-N-0904.
URL:https://globalbiodefense.com/event/vrbpac-meeting-to-review-pediatric-infant-5-years-mrna-vaccines/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:https://www.youtube.com/watch?v=Ixm4UmldTGQ
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220614T083000
DTEND;TZID=America/New_York:20220614T170000
DTSTAMP:20220527T205853Z
CREATED:20220527T205356Z
LAST-MODIFIED:20220527T205853Z
UID:55113-1655195400-1655226000@globalbiodefense.com
SUMMARY:VRBPAC Meeting to Review Moderna Pediatric (Ages 6-17) mRNA Vaccine EAU
DESCRIPTION:The VRBPAC committee will meet in open session on June 14\, 2022 to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to children and adolescents 6 years through 17 years of age. \nFDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its website prior to the meeting\, any background material will be made publicly available at the time of the advisory committee meeting\, and additional materials will be posted on FDA’s website after the meeting. \nMaterials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page. \nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. The Docket Number is FDA-2022-N-0904 \nOn June 15\, 2022\, under Topic II\, the committee will meet in open session to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age\, and also to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age. \n  \n  \n 
URL:https://globalbiodefense.com/event/vrbpac-meeting-to-review-moderna-pediatric-ages-6-17-mrna-vaccine-eau/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:https://www.youtube.com/watch?v=GbNpaZeDPiA
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220330T130000
DTEND;TZID=America/New_York:20220330T153000
DTSTAMP:20220323T181737Z
CREATED:20220323T163049Z
LAST-MODIFIED:20220323T181737Z
UID:54546-1648645200-1648654200@globalbiodefense.com
SUMMARY:Inaugural Joint Meeting of NACSD and NACIDD
DESCRIPTION:Please join Assistant Secretary for Preparedness and Response Dawn O’Connell along with Assistant Secretary for Aging and Acting Administrator for Community Living Alison Barkoff\, Wednesday\, March 30 from 1:00 p.m. to 3:30 p.m. ET for the inaugural meeting of the National Advisory Committee on Seniors and Disasters (NACSD) and National Advisory Committee on Individuals with Disabilities and Disasters (NACIDD). \nAdvanced registration for this meeting is required and can be accessed\, along with additional meeting information\, through the online event page. \nDuring this joint meeting\, committee members will be sworn into service and begin a national discussion with federal subject matter experts on the challenges\, opportunities\, and priorities in meeting the unique health needs of older adult populations and people with disabilities during and after disasters and public health emergencies. \nThe agenda includes time to hear from the public. The floor will be open to hear as many relevant comments as possible. To learn how to request a speaking time\, please visit our event page. Meeting materials also will be made publicly available through that page. You can send questions about the NACSD to NACSD@hhs.gov and questions about the NACIDD to NACIDD@hhs.gov. \nBackground \nThe National Advisory Committee on Seniors and Disasters (NACSD) and the National Advisory Committee on Individuals With Disabilities and Disasters (NACIDD)\, or Committees\, were established by sections 2811B and 2811C\, respectively\, of the Public Health Service (PHS) Act\, as amended by the Pandemic and All Hazards Preparedness and Advancing Innovation Act (PAHPAIA) of 2019. The Committees are governed by the provisions of the Federal Advisory Committee Act (FACA) and the General Services Administration FACA Final Rule. The Committees evaluate issues and programs and provide findings\, advice\, and recommendations to the Secretary of HHS to support and enhance all-hazards public health and medical preparedness\, response\, and recovery. The NACSD provides focus on the unique needs of older adults\, while the NACIDD focuses on helping HHS meet the needs of people with disabilities (PWD). The Secretary of HHS has formally delegated authority to operate the NACSD and the NACIDD to ASPR. \nFor Further Information:\nDr. Maxine Kellman\, NACSD Designated Federal Official\, 202-260-0447\, NACSD@hhs.gov; Tabinda Burney\, NACIDD Designated Federal Official\, 202-699-1779\, NACIDD@hhs.gov. Office of the Assistant Secretary for Preparedness and Response (ASPR)\, Department of Health and Human Services (HHS)\, Washington\, DC. \nLearn more and register at the ASPR website \n 
URL:https://globalbiodefense.com/event/national-advisory-committee-on-seniors-and-disasters-nacsd-and-national-advisory-committee-on-individuals-with-disabilities-and-disasters-nacidd/
CATEGORIES:Conference,Government Hosted
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/03/nacidd-individuals-disabilities-disasters-seniors-disasters-aspr.jpg
LOCATION:https://hhsasproea.zoomgov.com/webinar/register/WN_qCfSOHCWT4qTywRzWw_3fA
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220307T133000
DTEND;TZID=America/New_York:20220307T150000
DTSTAMP:20220305T134424Z
CREATED:20220303T133528Z
LAST-MODIFIED:20220305T134424Z
UID:54171-1646659800-1646665200@globalbiodefense.com
SUMMARY:National Biodefense Science Board Public Meeting
DESCRIPTION:The next public meeting of the National Biodefense Science Board (NBSB) will take place Monday\, 7 March 2022 from 1:30pm – 3:00pm ET via Zoom. \nJoin federal leaders\, National Biodefense Science Board members\, distinguished guests\, and other experts to discuss topics related to the public health supply chain and climate change.  NBSB will hear from the HHS Office of Climate Change and Health Equity and Joint Program Executive Office for Chemical\, Biological\, Radiological\, and Nuclear Defense (JPEO-CBRND) during the meeting. \nSubject matter experts from industry; academia; health systems; health consumer organizations; state\, local\, tribal\, and territorial public health; and emergency management agencies will also have an opportunity to provide comments to the NBSB on national priorities for biodefense and health security. Individual remarks will be limited to seven minutes each and the display of images and/or slides for public speakers will not be available. \nRequests to provide remarks to the NBSB during the public meeting must be sent to NBSB@hhs.gov by March 4\, 2022. In that request\, please provide the speaker’s name\, title\, and position with a brief summary of planned comments. The number of speakers and topics will be based on relevance to the mission of the NBSB and amount of time available on the agenda.  Those selected for public comments will receive confirmation by email prior to the meeting date with additional instructions. \nRegistration for this event is required and can be accessed along with additional meeting information through the online event page.  We encourage you to share this engagement information broadly across your network in advance of the meeting. \nMeeting materials will be made available to the public on the National Biodefense Science Board webpage. For any additional information or questions specific to this event\, please contact NBSB@hhs.gov directly.
URL:https://globalbiodefense.com/event/national-biodefense-science-board-public-meeting-3/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:https://hhsasproea.zoomgov.com/webinar/register/WN_DdvW3yVpTuGWSIey8ZsfBg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20211216
DTEND;VALUE=DATE:20211217
DTSTAMP:20211106T220805Z
CREATED:20211106T220727Z
LAST-MODIFIED:20211106T220805Z
UID:50876-1639612800-1639699199@globalbiodefense.com
SUMMARY:National Biodefense Science Board Meeting
DESCRIPTION:The National Biodefense Science Board (NBSB) will meet in public (virtually) on December 16\, 2021\, to provide advice and recommendations to ASPR regarding the development of the 2023-2026 National Health Security Strategy and to discuss other matters of current important for public health emergency preparedness\, response\, and recovery. \n\n\n\nA more detailed agenda will be available on the NBSB meeting website https://www.phe.gov/​nbsb. \n\n\n\nProcedures for Public Participation\n\n\n\nMembers of the public may attend the meeting via a toll-free phone number or Zoom teleconference\, which requires pre-registration. The meeting link to pre-register will be posted on the meeting website https://www.phe.gov/​nbsb. Members of the public may provide written comments or submit questions for consideration by the NBSB at any time via email to NBSB@hhs.gov. \nSource: Federal Register Notice
URL:https://globalbiodefense.com/event/national-biodefense-science-board-meeting/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20211208T090000
DTEND;TZID=America/New_York:20211208T103000
DTSTAMP:20240623T192553Z
CREATED:20211005T192345Z
LAST-MODIFIED:20240623T192553Z
UID:50043-1638954000-1638959400@globalbiodefense.com
SUMMARY:Current Concepts in Quantitative Risk Assessment for Skin Sensitization
DESCRIPTION:The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) is partnering with the Swiss Centre for Applied Human Toxicology and the Swiss State Secretariat for Economic Affairs to present a webinar series on “Current Concepts in Quantitative Risk Assessment for Skin Sensitization.” \nThe next webinar in the series on December 8 will consider the topics of methods for skin sensitization hazard and potency determination using currently available non-animal test methods\, as well as exposure assessment and quantification. \nThe webinar series is free and open to the public. Those who registered to view the first webinar are automatically registered for the second webinar. \nInformation and a link to register are available at https://ntp.niehs.nih.gov/go/ssqra-web. A video from the first webinar in the series\, which presented an introduction to skin sensitization and contact dermatitis\, will be posted on this page when available. \nRegister for the December 8 webinar: “Methods for hazard and exposure assessment”
URL:https://globalbiodefense.com/event/current-concepts-in-quantitative-risk-assessment-for-skin-sensitization/
CATEGORIES:Conference,Government Hosted,Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20211130T090000
DTEND;TZID=America/New_York:20211130T170000
DTSTAMP:20211111T191610Z
CREATED:20211111T191610Z
LAST-MODIFIED:20211111T191610Z
UID:50925-1638262800-1638291600@globalbiodefense.com
SUMMARY:Antimicrobial Drugs Advisory Committee (AMDAC) Meeting
DESCRIPTION:The FDA Antimicrobial Drugs Advisory Committee (AMDAC) will convene on 30 November 2021 to discuss Merck and Ridgeback’s request for emergency use (EUA) of molnupiravir oral capsules for treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. an investigational antiviral drug to treat COVID-19. \nFDA intends to make background material available to the public no later than two (2) business days before the meeting. \nBackground material and the link to the online teleconference meeting room will be available at 2021 Meeting Materials\, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee. \nPublic Participation Information\nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. \nFDA is establishing a docket for public comment on this meeting. The docket number is FDA-2021-N-0758. The docket will close on November 29\, 2021. Submit either electronic or written comments on this public meeting by November 29\, 2021. \nComments received on or before November 15\, 2021\, will be provided to the committee(s). Comments received after that date but by November 29\, 2021\, will be taken into consideration by FDA. \nLearn more at the FDA meeting announcement website. \n  \n 
URL:https://globalbiodefense.com/event/antimicrobial-drugs-advisory-committee-amdac-meeting/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20211116T090000
DTEND;TZID=America/New_York:20211116T160000
DTSTAMP:20211111T192222Z
CREATED:20211104T181912Z
LAST-MODIFIED:20211111T192222Z
UID:50927-1637053200-1637078400@globalbiodefense.com
SUMMARY:Enhanced Drug Distribution Security at the Package Level
DESCRIPTION:The FDA will hold a virtual public meeting on November 16\, 2021\, on enhanced drug distribution security at the package level. \nThe purpose of this public meeting is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to provide input to FDA on the implementation of the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) that go into effect in 2023. \nFDA requests that stakeholders prepare comments responding to the following questions for one or more of the topics listed below: \n\nHow is implementation of the 2023 enhanced system requirements progressing for your organization?\nWhat challenges is your organization facing?\nAre the proposed recommendations in FDA’s guidance on enhanced drug distribution security at the package level helpful to achieve compliance with 2023 enhanced system requirements? If not\, what additional information would be useful?\nAre there areas in which FDA could provide more clarity?\n\nTopics\n\nEnhanced Drug Distribution Security\n\nSystem Attributes\nAggregation\, Inference\, and Physical Security Features\n\n\nSystem Structure\n\nData Architecture\nAdoption of Data and System Security\nProtecting Confidential Commercial Information and Trade Secrets\nSystem Access and Data Retrieval\n\n\nEnhanced Product Tracing\n\nSerialized Transaction Information and Data Exchange (Incorporation of the Product Identifier into Product Tracing Information)\nResponsibilities of the Selling and Buying Trading Partners with regard to the Product Tracing Information\nHandling Aggregation Errors and Other Discrepancies\n\n\nGathering of Relevant Product Tracing Information\nEnhanced Verification\n\nVerification of Distributed Product\nVerification of Saleable Return Product\nAlerts for Illegitimate Product\n\n\nTrading Partner Readiness\n\nYour organization’s overall readiness for implementation\nComponents that your organization is furthest along in developing\, including the components being prioritized and the components that are easier or more challenging to implement\n\n\n\nAdditional Information\n\nEnhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Draft Guidance for Industry\nFDA Webinar on October 5\, 2021: Enhanced Drug Distribution Security in 2023 Under the DSCSA
URL:https://globalbiodefense.com/event/enhanced-drug-distribution-security-at-the-package-level/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20211104
DTEND;VALUE=DATE:20211106
DTSTAMP:20211014T233809Z
CREATED:20211014T233450Z
LAST-MODIFIED:20211014T233809Z
UID:50256-1635984000-1636156799@globalbiodefense.com
SUMMARY:NIH 2021 Synthetic Biology Consortium
DESCRIPTION:The 2021 Annual Synthetic Biology Consortium Meeting will take place in virtual format from November 4-5\, 2021. \nThe 2021 Synthetic Biology Consortium Meeting will facilitate networking and collaboration among synthetic biology investigators. Attendees can use this meeting to collaborate with each other on current topics in synthetic biology and engage with NIH program directors. \nHighlighted presenters and panelists include: \n\nKaren Elkins\, FDA\, Center for Biologics Evaluation and Research\nMichelle Bond\, NIGMS\, Division of Pharmacology\, Physiology\, and Biological Chemistry\nTuba Fehr\, NICHD\, Development Biology and Structural Variation Branch\nTim Lu\, Massachusetts Institute of Technology\nGary Lee\, Senti Biosciences\nStephanie Morris\, NHGRI\, Division of Genome Sciences\nBrigitte Sanders\, NIAID\, Division of AIDS\nHye-Sook Kim\, NCCIH\, Basic and Mechanistic Research\nTatjana Atanasijevic\, NIBIB\, Division of Applied Science and Technology (Bioimaging)\nParijat Bhatnagar\, SRI International\nJoshua Leonard\, Northwestern University\nTara Deans\, The University of Utah\nDave Rampulla\, NIBIB\, Division of Discovery Science and Technology (Bioengineering)\nRahul Thakar\, NHLBI\, Advanced Technologies and Surgery Branch\nRyan Richardson\, NINDS\, Office of the BRAIN Director\nJerry Li\, NCI\, Structural Biology and Molecular Applications Branch\nKelly Crotty\, NCI\, Center for Strategic Scientific Initiatives\nJiahe Li\, Northeastern University\nTal Danino\, Columbia University\nAndrew Ellington\, University of Texas at Austin\nOphelia Venturelli\, University of Wisconsin-Madison\n\nPlease visit NIH’s 2021 Synthetic Biology Consortium meeting site for more information. \n 
URL:https://globalbiodefense.com/event/nih-2021-synthetic-biology-consortium/
CATEGORIES:Conference,Government Hosted,Webinar-Webcast
LOCATION:https://www.zoomgov.com/meeting/register/vJItfu-hpzIiHqmy-7yogDu9ImlF2Lfd0iE
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20211103
DTEND;VALUE=DATE:20211105
DTSTAMP:20210812T192722Z
CREATED:20210812T192722Z
LAST-MODIFIED:20210812T192722Z
UID:49489-1635897600-1636070399@globalbiodefense.com
SUMMARY:BARDA Industry Day 2021 – BID2021
DESCRIPTION:This BARDA Industry Day 2021 Virtual Event will be held 3-4 November 2021. \nThis annual gathering of more than 1300 stakeholders from the public and private sector provides an opportunity to increase understanding of the U.S. government medical countermeasure priorities and funding goals; interact with BARDA and ASPR staff; and showcase innovations. \nInnovators may apply for limited openings to present during Lightning Talks sessions. Lightning Talks are for individuals\, academic institutions\, pharmaceutical companies\, biotech\, and other industry innovators to showcase their innovative technologies. \nTo submit your application for the Lightning Talks\, please enter the requested information and provide a brief (maximum 500 words) summary of your proposed presentation\, with one optional PowerPoint slide\, by 16 August. \nVisit the BARDA Industry Day website for more information. \n  \n 
URL:https://globalbiodefense.com/event/barda-industry-day-2021-bid2021/
CATEGORIES:Conference,Government Hosted,Industry Day
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2021/08/bid-2021-barda-industry-day.jpg
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20211026
DTEND;VALUE=DATE:20211027
DTSTAMP:20211004T010523Z
CREATED:20211004T010523Z
LAST-MODIFIED:20211004T010523Z
UID:50037-1635206400-1635292799@globalbiodefense.com
SUMMARY:VRBPAC Meeting on Pfizer Data on Its COVID-19 Vaccine for Children 5-11
DESCRIPTION:The FDA anticipates receiving a request from Pfizer to amend its emergency use authorization to allow the use of its COVID-19 vaccine in children 5 through 11 years of age. In anticipation of the request\, the FDA is scheduling an Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Oct. 26 to inform the agency’s decision-making. \nThe FDA intends to make background materials for both VRBPAC meetings available to the public\, including the meeting agendas and committee rosters\, no later than two business days before each meeting. \nThe FDA intends to livestream the VRBPAC meetings on the agency’s YouTube page.
URL:https://globalbiodefense.com/event/vrbpac-meeting-on-pfizer-data-on-its-covid-19-vaccine-for-children-5-11/
CATEGORIES:Government Hosted,Webinar-Webcast
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2021/10/fda-vrbpac-covid-vaccine-children-meeting-oct-2021.jpg
LOCATION:https://www.youtube.com/watch?v=laaL0_xKmmA
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20211020T100000
DTEND;TZID=America/New_York:20211021T170000
DTSTAMP:20210925T181613Z
CREATED:20210925T181613Z
LAST-MODIFIED:20210925T181613Z
UID:49859-1634724000-1634835600@globalbiodefense.com
SUMMARY:Advisory Committee on Immunization Practices (ACIP) Meeting
DESCRIPTION:The CDC Advisory Committee on Immunization Practices will convene 20-21 October 2021. ACIP typically holds three meetings each year at CDC in Atlanta\, Georgia to make vaccine recommendations. Due to the coronavirus disease 2019 (COVID-19) pandemic\, ACIP meetings have been held more frequently and have been virtual only (no in-person attendance). \nThe agenda will include discussions on adult immunization schedule\, child/adolescent immunization schedule\, Ebola vaccine\, hepatitis vaccines\, herpes zoster vaccines\, Orthopoxviruses vaccine\, influenza vaccines\, pneumococcal vaccine\, cholera vaccine and tickborne encephalitis vaccine. Recommendation votes on adult immunization schedule\, child/adolescent immunization schedule\, hepatitis vaccine\, herpes zoster vaccine\, Orthopoxviruses vaccine\, pneumococcal vaccine and Ebola vaccine are scheduled. No Vaccines for Children votes are scheduled. Agenda items are subject to change as priorities dictate. For more information on the meeting agenda visit https://www.cdc.gov/​vaccines/​acip/​meetings/​meetings-info.html. \nPublic Participation\nInterested persons or organizations are invited to participate by submitting written views\, recommendations\, and data. Please note that comments received\, including attachments and other supporting materials\, are part of the public record and are subject to public disclosure. Comments will be posted on https://www.regulations.gov. Therefore\, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name\, contact information\, or other information that identifies you in the body of your comments\, that information will be on public display. CDC will review all submissions and may choose to redact\, or withhold\, submissions containing private or proprietary information such as Social Security numbers\, medical information\, inappropriate language\, or duplicate/near duplicate examples of a mass-mail campaign. CDC will carefully consider all comments submitted into the docket. \nWritten Public Comment: The docket will be opened to receive written comments on October 1\, 2021. Written comments must be received on or before October 21\, 2021. \nOral Public Comment: This meeting will include time for members of the public to make an oral comment. Oral public comment will occur before any scheduled votes including all votes relevant to the ACIP’s Affordable Care Act and Vaccines for Children Program roles. Priority will be given to individuals who submit a request to make an oral public comment before the meeting according to the procedures below. \nProcedure for Oral Public Comment: All persons interested in making an oral public comment at the October 20-21\, 2021 ACIP meeting must submit a request at http://www.cdc.gov/​vaccines/​acip/​meetings/​no later than 11:59 p.m.\, EDT\, October 18\, 2021\, according to the instructions provided. \nIf the number of persons requesting to speak is greater than can be reasonably accommodated during the scheduled time\, CDC will conduct a lottery to determine the speakers for the scheduled public comment session. CDC staff will notify individuals regarding their request to speak by email by October 19\, 2021. To accommodate the significant interest in participation in the oral public comment session of ACIP meetings\, each speaker will be limited to 3 minutes\, and each speaker may only speak once per meeting. \nThe Director\, Strategic Business Initiatives Unit\, Office of the Chief Operating Officer\, Centers for Disease Control and Prevention\, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities\, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. \nACIP consists of 15 experts who are voting members and are responsible for making vaccine recommendations. The Secretary of the U.S. Department of Health and Human Services (DHHS) selects these members after an application and nomination process. Fourteen of these members have expertise in vaccinology\, immunology\, pediatrics\, internal medicine\, nursing\, family medicine\, virology\, public health\, infectious diseases\, or preventive medicine. One member is a consumer representative who provides perspectives on the social and community aspects of vaccination. \nAll of ACIP’s recommendations are posted online. Once they are reviewed and approved by the CDC Director and Department of Health and Human Services\, recommendations are published in the CDC’s MMWR. \nThe MMWR publication represents the official CDC recommendations for immunizations of the U.S. population.
URL:https://globalbiodefense.com/event/advisory-committee-on-immunization-practices-acip-meeting/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20211014
DTEND;VALUE=DATE:20211016
DTSTAMP:20211004T005916Z
CREATED:20211004T005916Z
LAST-MODIFIED:20211004T005916Z
UID:50034-1634169600-1634342399@globalbiodefense.com
SUMMARY:VRBPAC Meeting on Janssen and Moderna COVID-19 Vaccine Boosters
DESCRIPTION:On Oct. 14 and 15\, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss the use of booster doses of the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine. Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older. The committee will also hear presentations and discuss the available data on the use of a booster of a different vaccine than the one used for the primary series of an authorized or approved COVID-19 vaccine (heterologous or “mix and match” booster). \nOn Oct. 14\, the committee will discuss an amendment to the emergency use authorization of the Moderna COVID-19 Vaccine for the administration of a booster dose\, in individuals 18 years of age and older. \nOn Oct. 15\, the VRBPAC will discuss amending the emergency use authorization of Johnson and Johnson’s Janssen COVID-19 Vaccine for the administration of a booster dose\, in individuals 18 years of age and older. \nAdditionally\, on Oct. 15\, the committee will hear a presentation from the National Institute of Health’s National Institute of Allergy and Infectious Diseases on the heterologous use of booster doses following the primary series of the three currently authorized or approved COVID-19 vaccines. \nDuring the meeting\, the committee will hear presentations from the companies on the data for their respective vaccines. The FDA will also present its own analyses of each of the manufacturers’ data. There will be an open public hearing each day during which the public will be given an opportunity to provide comments. \nThe FDA intends to make background materials for both VRBPAC meetings available to the public\, including the meeting agendas and committee rosters\, no later than two business days before each meeting. \nThe FDA intends to livestream the VRBPAC meetings on the agency’s YouTube page.
URL:https://globalbiodefense.com/event/vrbpac-meeting-on-janssen-and-moderna-covid-19-vaccine-boosters/
CATEGORIES:Government Hosted,Webinar-Webcast
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2021/10/fda-vrbpac-mix-match-booster-shots-janssen-moderna-boosters-covid-19.jpg
LOCATION:https://www.youtube.com/watch?v=BhlshZ7Lkr0
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20210929
DTEND;VALUE=DATE:20210930
DTSTAMP:20210919T003055Z
CREATED:20210919T003055Z
LAST-MODIFIED:20210919T003055Z
UID:49670-1632873600-1632959999@globalbiodefense.com
SUMMARY:TEI-REX Proposer's Day
DESCRIPTION:The Intelligence Advanced Research Projects Activity (IARPA) will hold a virtual Proposers’ Day for the TEI-REX Program (Targeted Evaluation of Ionizing Radiation Exposure) on September 29\, 2021 from 10:00 am to 5:00 pm EDT with potential overflow into September 30\, 2021 from 10:00 am to 1:00 pm. \nThe TEI-REX Proposers’ Day meeting will be used to introduce the research requirements to potential performers and provide information on program objectives. The TEI-REX Program aims to establish novel biodosimetry approaches enabling improved quantification of low-dose ionizing radiation exposures (<0.75 Gray) from minimally and non-invasive samples\, while also expanding quantitative and qualitative knowledge of the exposure environment. \nIARPA holds Proposers’ Days to provide information to assist potential proposers to evaluate whether and how they might respond to the Government’s research and development solicitations and to increase efficiency in proposal preparation and evaluation. The TEI-REX Proposers’ Day is open only to registered potential proposers\, and not to the media or the general public. \nThe meeting will be held entirely on the WebEx video conference platform\, and a recorded video of the meeting will be made available to the public on the IARPA website. \nPre-registration is required and closes on September 24\, 2021 at 5:00 pm EDT. \nOpportunities to facilitate teaming are available to registrants for the TEI-REX Proposers’ Day. IARPA highly encourages potential proposers to establish strong teams capable of addressing the technical challenges TEI-REX aims to overcome. \nThis meeting will include an introduction to IARPA\, an overview of the program\, technical challenges\, and expected participation requirements. Before the Proposers’ Day meeting\, attendees may submit comments or questions regarding TEI-REX by emailing the program manager (contact information at the event link).
URL:https://globalbiodefense.com/event/tei-rex-proposers-day/
CATEGORIES:Government Hosted,Industry Day
LOCATION:
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DTSTART;TZID=America/New_York:20210928T110000
DTEND;TZID=America/New_York:20210928T130000
DTSTAMP:20210925T183006Z
CREATED:20210915T181953Z
LAST-MODIFIED:20210925T183006Z
UID:49861-1632826800-1632834000@globalbiodefense.com
SUMMARY:National Biodefense Science Board Public Meeting
DESCRIPTION:The National Biodefense Science Board (NBSB) will convene to discuss the strategy and planning for the National Special Pathogen System and other high priority issues related to national public health emergency preparedness and response. \nThe meeting is open to the public and will be held in a virtual format on September 28\, 2021. The NBSB invites those who are involved in or represent a relevant industry\, academia\, health profession\, health care consumer organization\, or state\, Tribal\, territorial or local government to request up to seven minutes to address the board in person via Zoom. \nRequests to provide remarks to the NBSB during the public meeting may be sent to NBSB@hhs.gov. Please include the name of the speaker\, organization\, and a full explanation of the intended comments. Please submit your request by 5PM ET on September 24\, 2021. \nABOUT THE NBSB \nThe National Biodefense Science Board (NBSB or the Board) is authorized under Section 319M of the Public Health Service (PHS) Act\, as added by Section 402 of the Pandemic and All-Hazards Preparedness Act of 2006 and amended by Section 404 of the Pandemic and All-Hazards Preparedness Reauthorization Act. The Board is governed by the Federal Advisory Committee Act\, which sets forth standards for the formation and use of advisory committees. The NBSB provides expert advice and guidance on scientific\, technical\, and other matters of special interest to the Department regarding current and future chemical\, biological\, nuclear\, and radiological agents\, whether naturally occurring\, accidental\, or deliberate. \nMembers of the public may attend the meeting via a toll-free phone number or Zoom teleconference\, which requires pre-registration. The meeting link to pre-register will be posted on https://www.phe.gov/​nbsb. Members of the public may provide written comments or submit questions for consideration by the NBSB at any time via email to NBSB@hhs.gov. Members of the public are also encouraged to provide comments after the meeting.
URL:https://globalbiodefense.com/event/national-biodefense-science-board-public-meeting-2/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
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