BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Global Biodefense - ECPv6.17.5.1//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:Global Biodefense
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:Asia/Kolkata
BEGIN:STANDARD
TZOFFSETFROM:+0530
TZOFFSETTO:+0530
TZNAME:IST
DTSTART:20210101T000000
END:STANDARD
END:VTIMEZONE
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:VTIMEZONE
TZID:Europe/Dublin
BEGIN:DAYLIGHT
TZOFFSETFROM:+0000
TZOFFSETTO:+0100
TZNAME:IST
DTSTART:20210328T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0100
TZOFFSETTO:+0000
TZNAME:GMT
DTSTART:20211031T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0000
TZOFFSETTO:+0100
TZNAME:IST
DTSTART:20220327T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0100
TZOFFSETTO:+0000
TZNAME:GMT
DTSTART:20221030T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0000
TZOFFSETTO:+0100
TZNAME:IST
DTSTART:20230326T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0100
TZOFFSETTO:+0000
TZNAME:GMT
DTSTART:20231029T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VTIMEZONE
TZID:America/Chicago
BEGIN:DAYLIGHT
TZOFFSETFROM:-0600
TZOFFSETTO:-0500
TZNAME:CDT
DTSTART:20210314T080000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0500
TZOFFSETTO:-0600
TZNAME:CST
DTSTART:20211107T070000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0600
TZOFFSETTO:-0500
TZNAME:CDT
DTSTART:20220313T080000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0500
TZOFFSETTO:-0600
TZNAME:CST
DTSTART:20221106T070000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0600
TZOFFSETTO:-0500
TZNAME:CDT
DTSTART:20230312T080000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0500
TZOFFSETTO:-0600
TZNAME:CST
DTSTART:20231105T070000
END:STANDARD
END:VTIMEZONE
BEGIN:VTIMEZONE
TZID:Asia/Singapore
BEGIN:STANDARD
TZOFFSETFROM:+0800
TZOFFSETTO:+0800
TZNAME:+08
DTSTART:20210101T000000
END:STANDARD
END:VTIMEZONE
BEGIN:VTIMEZONE
TZID:Asia/Dubai
BEGIN:STANDARD
TZOFFSETFROM:+0400
TZOFFSETTO:+0400
TZNAME:+04
DTSTART:20210101T000000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220920
DTEND;VALUE=DATE:20220925
DTSTAMP:20220829T233259Z
CREATED:20220829T233259Z
LAST-MODIFIED:20220829T233259Z
UID:56263-1663632000-1664063999@globalbiodefense.com
SUMMARY:21st Congress of the International Society for Human and Animal Mycology
DESCRIPTION:The 21st Congress of the International Society for Human and Animal Mycology will be \nHighlighted topics of interest include: \n\nVeterinary relevant and zoonotic fungal groups\nDevelopment of WHO priority pathogens list of public health importance\nAMR fungal infections global burden: surveillance challenges\, gap & opportunities: WHO GLASS pilot\nUnraveling the genetic determinants of virulence in Cryptococcus\nWHO first antifungals clinical & preclinical pipeline review\nDiagnostic Rounds Interactive session for diagnosis of emerging and re-emerging fungal infections\nAntifungal activity of antimicrobial synthetic peptides against Candida species of public health importance\nHigh rate of chronic pulmonary aspergillosis in active TB patients in Indonesia with GeneXpert positive?\nDevelopment of a breath-based diagnostic for valley fever\, an endemic fungal pneumonia\nInvestigation of in vitro antifungal susceptibility testing and genetic diversity of clinical isolates of Trichophyton benhamiae and Trichophyton eriotrephon in Iran\nShould we continue to use conventional doses of candins for all ICU patients?\nParadigm shift in the epidemiology of invasive fungal infections during COVID-19 pandemics\nCryptococcus qPCR assays: the future for routine mycology labs and clinical trials dealing cryptococcosis\nEvaluation of new tools for the diagnosis of histoplasmosis\nAgrochemicals potentiate multidrug resistance and alter virulence in Cryptococcus neoformans via hitch-hiking effect of aneuploidy\nFuture of molecular typing in fungi\nStanding Up FungiNet: Genomic epidemiology and surveillance of fungal diseases\nStandardization of diagnostic mycology laboratories\nWhy sporotrichosis and Paracoccidioidomycosis should be considered neglected tropical disease\n\nPlease visit the ISHAM website to register for the 21st Congress of the International Society for Human and Animal Mycology meeting.
URL:https://globalbiodefense.com/event/21st-congress-of-the-international-society-for-human-and-animal-mycology/
LOCATION:Hotel de Ashok\, 50\, Niti Marg\, Diplomatic Enclave\, New Delhi\, Chanakyapuri\, 110021\, India
CATEGORIES:Conference
ORGANIZER;CN="International Society for Human and Animal Mycology (ISHAM)":MAILTO:isham2022@congresscare.com
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;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;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: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;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: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: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;VALUE=DATE:20220929
DTEND;VALUE=DATE:20221001
DTSTAMP:20220922T194342Z
CREATED:20220922T194342Z
LAST-MODIFIED:20220922T194342Z
UID:56478-1664409600-1664582399@globalbiodefense.com
SUMMARY:Managing for Supply Chain Resilience Course
DESCRIPTION:NDIA’s Business Institute and Carnegie Mellon University’s Software Engineering Institute will host a Managing for Supply Chain Resilience Course from 29-30 September 2022 to will explore the sources and types of supply chain risks and provide practical guidance on how to manage these in alignment with business strategy. \nThe course includes an examination of prominent frameworks and standards (e.g.\, NIST Special Publication 171 and the Cybersecurity Maturity Model Certification) and the fundamental tools (e.g.\, Service Level Agreements\, and Software Bill of Materials) required to effectively quantify and manage supply chain risk.  No prior technical cybersecurity knowledge or experience is required. \nPlease visit NDIA’s Managing for Supply Chain Resilience Course event page for more information and registration.
URL:https://globalbiodefense.com/event/managing-for-supply-chain-resilience-course/
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:20221003
DTEND;VALUE=DATE:20221008
DTSTAMP:20220922T183847Z
CREATED:20220922T183847Z
LAST-MODIFIED:20220922T183847Z
UID:56471-1664755200-1665187199@globalbiodefense.com
SUMMARY:AAAR 2022 - American Association for Aerosol Research
DESCRIPTION:Experts and stakeholders in aerosol science of infectious diseases and indoor air quality will gather in North Carolina this October. \nThe 40th AAAR Annual Conference of the American Association for Aerosol Research will take place 3-7 October 2022 in Raleigh\, North Carolina. \nSpecial Symposia designed to bridge multiple areas and promote cross-disciplinary interaction will be held on the following topics: \n\nBiomass Combustion: outdoor/indoor transport and indoor air quality\nAerosol Physical Chemistry and Microphysics\nAerosol Science of Infectious Diseases: What we’ve learned and still need to know about transmission\, prevention\, and the one health concept\nAerosol sources and constituents of emerging importance and their impacts across spatial scales\n\nHighlighted topics and sessions include: \n\nOptimization of a Wetted Wall Cyclone for Pathogen Collection\nImpact of Chemically Reductive Trace Air Contaminants on Non-thermal Plasma Inactivation of Airborne Viruses\nModeling of the Atmospheric Process of Cyanobacterial Toxins in Algal Aerosol\nAssessment of the Effectiveness of a Hygroscopic Coating on the Conservation of MS2 Viability during Aerosol Sampling with MCE Filters\nContinuous Fluorescent Bioaerosol Measurements for 18 Months Combined with Filter Sampling Validation\nCharacterization of Aerosol in Poultry Farms with Low-Cost Sensors and Research-Grade Instruments\nComparison of Airborne Bacterial Diversity Collected by Passive and Active Air Sampling\nPerformance of Low-cost PurpleAir Sensor in Monitoring Indoor Aerosols\nInfluence of UV Irradiation and Environmental Factors on the Size-Dependent Survivability of Bioaerosols\nWhat is the Best Cleaning Method the Public Can Use to Remove Bacillus Spores from Indoor Surfaces?\nAntibiotic Resistance Genes in Air Near Farms\nFate of Inhaled Particles in the Lungs of Ferrets\nPerformance of N95 Filtering Facepiece Respirators Used with Skin Protectants: Manikin-based Study\nSeasonal Impacts on Microbiome Diversity and Antibiotic Resistance Patterns in Aerosolized Bacteria in a Dairy Facility\nAgricultural Contributions to Fluorescent Bioaerosol Measured by the WIBS at the AGINSGP Campaign at the Southern Great Plains Site\nQualitative Analysis of Bioaerosol Chemical Composition and Shift by Means of 1HNMR\nU.S. EPA Progress on Developing Performance Testing Protocols and Targets for Particulate Matter Air Sensors\nToxicological Impact of Secondary Organic Aerosol Compounds in Air-Liquid-Interface Exposed Lung Cell Models\nTrapped in the Inversion Layer: Composition and Morphology of Single Aerosol Particles in the Urban Arctic Winter\nExploring the Chemical Evolution of Aerosol Particle Composition and Physical Properties using Single Particle Levitation\nGlobal vs. Local Dose Deliveries of Airborne Particles through Dosimetric Aerosol in Vitro Inhalation Device (DAVID)\nUltrafine Aerosol Particle Formation and Impacts in Houston during TRACER\nEffects of Wet Removal on Aerosol Mass and Chemical Composition\nInvestigating the Fate of wildfire Smoke in Homes\nImpact of Do-It-Yourself and Commercial Air Cleaner Use on Residential PM2.5 in a Smoke-Impacted Community\nDeveloping National Exposure Models for Source-Specific Primary Particulate Matter Concentrations Using Aerosol Mass Spectrometry Data\nThe Peroxy Radical Fates during Heterogeneous Oxidation of Organic Aerosols\nComparison of Organic Aerosol Composition and Source Distributions across Different Urban Microenvironments\nCharacterization of VOC and Particle Emissions in Exhaled Air during Vaping\nPersonal Exposure of Domestic Dogs and Their Owners to Airborne Per- and Polyfluoroalkyl Substances (PFAS)\nRisk Assessment of Ambient Toxic Aerosols and Gases Among Firefighters During Fire Training\nSeasonal Variation in Ambient Air Pollutants and Influence of Meteorological Factors in an Urban Environment\nCharacterizing the Seasonal Sources of Urban Organic Aerosol Using the Non-Targeted High-Resolution Mass Spectrometry and Factor Analysis\nVolatile Chemical Product Contributions to the Urban Secondary Organic Aerosol Burden\nMeasuring and Modeling Ultrafine Particle Growth by Isoprene Ozonolysis Secondary Organic Aerosol\n\nPlease visit the American Association for Aerosol Research 2022 Conference website for more information and to register.
URL:https://globalbiodefense.com/event/aaar-2022-american-association-for-aerosol-research/
LOCATION:Raleigh Convention Center\, 500 S Salisbury St.\, Raleigh\, NC\, 27601\, United States
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221004
DTEND;VALUE=DATE:20221008
DTSTAMP:20220420T231323Z
CREATED:20220420T231135Z
LAST-MODIFIED:20220420T231323Z
UID:54819-1664841600-1665187199@globalbiodefense.com
SUMMARY:ESCMID-ASM Drug Development to Meet the Challenge of AMR
DESCRIPTION:The 2022 ESCMID/ASM Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance is scheduled to take place Oct. 4-7\, 2022 in Dublin\, Ireland. \nAntimicrobial drug resistance (AMR) is an urgent global health problem. New antimicrobial drug development is increasingly viewed as a priority by national and international bodies. Co-sponsored by the American Society for Microbiology (ASM) and the European Society for Clinical Microbiology and Infectious Diseases (ESCMID)\, this multidisciplinary meeting will address the challenges\, opportunities and current requirements for antimicrobial drug development to address antimicrobial resistance. \nAbstracts can be submitted until 27 June 2022 in the following categories: \n\nDrug discovery\nDrug development\nNovel therapeutics\nPreclinical development\nNew antibacterial classes\nNon-traditionals\nClinical development\nStewardship\n\nPlease visit the ESCMID website to register for the Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance 2022.
URL:https://globalbiodefense.com/event/escmid-asm-drug-development-to-meet-the-challenge-of-amr/
LOCATION:Dublin\, Ireland\, Dublin\, Ireland
CATEGORIES:Conference
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: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: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: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:20221013T120000
DTEND;TZID=America/New_York:20221013T130000
DTSTAMP:20220921T205205Z
CREATED:20220921T205205Z
LAST-MODIFIED:20220921T205205Z
UID:56440-1665662400-1665666000@globalbiodefense.com
SUMMARY:Quality Considerations for MAM for Therapeutic Proteins
DESCRIPTION:The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS) based peptide mapping approach used for the identification and quantitation of product quality attributes (PQAs) in therapeutic proteins. \nThe U.S. FDA Center for Drug Evaluation and Research (CDER)\, Emerging Technology Program (ETP) has assessed the use of MAM in quality control environments and laboratory resources have been developed to improve the FDA’s understanding of the approach. \nThis meeting will discuss: \n\nHow the LC-MS based multi-attribute method can be used for quality control of therapeutic proteins\nHow the multi-attribute method can detect multiple product quality attributes or critical quality attributes within a single LC-MS run\nKey considerations for implementation of the multi-attribute method\, including risk assessment\, method validation\, new peak detection\, and conventional method comparisons\n\nFor advance registration\, please visit the MAM for Therapeutic Proteins meeting page
URL:https://globalbiodefense.com/event/quality-considerations-for-mam-for-therapeutic-proteins/
CATEGORIES:Government Hosted
LOCATION:https://fda.zoomgov.com/webinar/register/WN_LKO4FXAlSfSuP89383sikg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221014
DTEND;VALUE=DATE:20221020
DTSTAMP:20220923T201223Z
CREATED:20220420T204952Z
LAST-MODIFIED:20220923T201223Z
UID:54794-1665705600-1666223999@globalbiodefense.com
SUMMARY:65th Annual Biosafety and Biosecurity Conference
DESCRIPTION:The ABSA’s 65th Annual Biosafety and Biosecurity Conference will be held 14-19 October 2022 in a hybrid virtual and in-person format in Milwaukee\, Wisconsin. \nThe event offers intensive professional development courses over three full days of state-of-the-art keynotes\, papers\, and panels highlighting best practices and hands-on skills crucial for today’s biosafety and biosecurity professionals. \nApproximately 700 attendees are expected and 70 exhibits will showcase the latest in laboratory biosafety and biosecurity products and services. \nTopics of interest for this meeting include: \n\nAgent Inactivation\nAnimal Biosafety\nArthropods and Biosafety\nBehavior/Enhancing Compliance\nBSL3-Ag or Large Animals\nBiosecurity\nCOVID-19\nDisinfection/Biowaste Management\nEmergency Response\nFacilities/Equipment (BSL-3)\nFacilities/Equipment (General)\nHuman Source Materials Mammalian Cell Lines\nIndustrial Biosafety\nInfectious Substance Transportation\nMicrobiology and Molecular Biology\nOccupational Health/Medical Surveillance/PE\nPractices/PPE (BSL-3)\nPractices/PPE (General)\nProgram Management\nPublic Health\nRegulatory Issues\nRisk Assessments\nShipping/Permits\nSynthetic Biology\nTraining\n\nSince ABSA International’s core purpose is dedicated to promoting and expanding biosafety and biosecurity expertise\, this is an excellent opportunity to display and discuss your products and services to an international audience. \nPlease visit the ABSA’s Annual Biosafety and Biosecurity Hybrid Conference 2022 website for more information.
URL:https://globalbiodefense.com/event/65th-annual-biosafety-and-biosecurity-conference/
LOCATION:Wisconsin Center\, 400 W. Wisconsin Ave.\, Milwaukee\, WI\, 53203\, United States
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221019
DTEND;VALUE=DATE:20221022
DTSTAMP:20220922T140954Z
CREATED:20220922T140800Z
LAST-MODIFIED:20220922T140954Z
UID:56448-1666137600-1666396799@globalbiodefense.com
SUMMARY:GSRS22 - 12th Global Summit on Regulatory Science
DESCRIPTION:GSRS22: The 12th Global Summit on Regulatory Science will be held from 19-21 October 2022 in Singapore. \nConvening under a theme of “Advances in Nanotechnology for Food and Medical Products: Innovations\, Safety and Standards”. the Summit will highlight topics including: \n\nNanomaterials for Gene Delivery\nNanotechnology in Agri-Products\nEmerging Nanomaterial Contaminants in Food\nGeneric Medical Products Containing Nanomaterial\nRole of Nanotechnology in Precision Medicine\nInnovation in Nanotechnology for Food\n\nThe Global Summit is free to attend\, but registration is required to attend the conference. \nThis event is being co-hosted by Singapore Food Agency (SFA) and the Global Coalition for Regulatory Science Research (GCRSR). \nPlease visit the GSRS22 website to register.
URL:https://globalbiodefense.com/event/gsrs22-12th-global-summit-on-regulatory-science/
LOCATION:Orchard Hotel Singapore\, 442 Orchard Road\, Singapore\, 238879\, Singapore
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221019T093000
DTEND;TZID=America/New_York:20221019T123000
DTSTAMP:20220922T190024Z
CREATED:20220922T185728Z
LAST-MODIFIED:20220922T190024Z
UID:56475-1666171800-1666182600@globalbiodefense.com
SUMMARY:CBRN Threats and Challenges - Fall Quarterly Update
DESCRIPTION:The NDIA will host a CBRN Threats and Challenges Fall Quarterly Update Forum on 19 October 2022. \nThis quarterly meeting is set to provide a SECRET-level classified update from government representatives in the Chemical and Biological Defense Program (CBDP). This update will inform industry and government attendees about the CB Threat concerns that the DASD is focused on and highlight the priority efforts to address those threats. The objective is to improve understanding across the community and help them to focus their efforts and resources in ways that align to the CBDP’s priorities. \nSpeakers include \n\nIan Watson\, Deputy ASD for Chemical and Biological Defense\nDarryl Colvin\, JPEO CBRND\n\nThis is a classified event. \nPlease visit NDIA’s CBRN Threats and Challenges – A Classified Update event page for more information.
URL:https://globalbiodefense.com/event/cbrn-threats-and-challenges-fall-quarterly-update/
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;VALUE=DATE:20221026
DTEND;VALUE=DATE:20221027
DTSTAMP:20220921T211348Z
CREATED:20220921T211237Z
LAST-MODIFIED:20220921T211348Z
UID:56442-1666742400-1666828799@globalbiodefense.com
SUMMARY:In-Depth Look at Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs
DESCRIPTION:The FDA will host a meeting on 26 October 2022 to provide additional clarity to the final guidance with respect to Agency expectations for submissions containing Bioavailability information for drug products\, and will discuss: \n\nSelect case studies on various bioavailability (BA) related subtopics (e.g. pharmacodynamic (PD) endpoints\, endogenous compound Narrow Therapeutic Index (NTI)\, biowaivers).\nBioavailability Studies Submitted in NDAs and INDs – General Considerations\nBioavailability Determination: Special Topics\nRelative Bioavailability Evaluation: Potential for Using Pharmacodynamic and Non-Traditional Pharmacokinetic Endpoints\nRecommended In Vitro Studies\n\nThe intended audience for this event is: Regulatory Scientists assessing bioavailability studies as part of IND/NDA/BLA submissions; Research Coordinators overseeing in vivo studies in the context of IND/NDA/BLA submissions; Drug Development/New Drug industry scientists involved with bioavailability studies for support of a new/existing IND/NDA/BLA dossier; and foreign regulators. \nPlease visit the FDA’s In-Depth Look at BA Final Guidance Meeting website to register. \nFDA RESOURCES\nFinal Guidance for Industry: Bioavailability Studies Submitted in NDAs or INDs — General Considerations
URL:https://globalbiodefense.com/event/in-depth-look-at-final-fda-guidance-bioavailability-studies-submitted-in-ndas-or-inds/
CATEGORIES:Continuing Education,Government Hosted
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
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221102
DTEND;VALUE=DATE:20221104
DTSTAMP:20220922T163745Z
CREATED:20220922T163745Z
LAST-MODIFIED:20220922T163745Z
UID:56469-1667347200-1667519999@globalbiodefense.com
SUMMARY:Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
DESCRIPTION:On November 2\, 2022\, the committee will discuss the Center for Drug Evaluation and Research (CDER) Quality Management Maturity (QMM) program. QMM is the state attained when drug manufacturers have consistent\, reliable\, and robust business processes to achieve quality objectives and promote continual improvement. CDER has proposed the development of a rating system that will help incentivize drug manufacturers to adopt more mature quality management practices at their facilities. The committee will consider the impact that a QMM program would have on the pharmaceutical industry\, drug shortages\, and supply chain resiliency. FDA will seek input to determine if experts from academia and industry support the development of a CDER QMM program to incentivize investments in mature quality management practices. \nOn November 3\, 2022\, as part of CDER’s continued effort to provide key updates on modernization of quality assessment\, the committee will discuss the next stages of Knowledge-Aided Assessment and Structured Application (KASA). The concept of KASA was envisioned in 2016 and discussed at the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting on September 20\, 2018\, as an IT system that modernizes FDA’s assessment. Through the development\, testing\, and implementation of various KASA prototypes\, the KASA system has been refined over the course of multiple years. FDA will seek input on the vision and plan to expand KASA over the next 5 years to include drug substances\, all generic dosage forms\, new drug and biologics applications\, and post-approval changes. Moreover\, FDA will seek input regarding the need for advancing digitalization in KASA\, including data standardization and mobilization of data from cloud-based servers. \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-1777. \nPlease visit the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement page for more information.
URL:https://globalbiodefense.com/event/pharmaceutical-science-and-clinical-pharmacology-advisory-committee-meeting/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221105
DTEND;VALUE=DATE:20221107
DTSTAMP:20220923T191814Z
CREATED:20220923T191704Z
LAST-MODIFIED:20220923T191814Z
UID:56486-1667606400-1667779199@globalbiodefense.com
SUMMARY:AACC Middle East
DESCRIPTION:AACC Middle East will be held 5-6 November in Dubai\, UAE in partnership with Life Dx. The event that brings the latest in laboratory medicine to the Middle East region and showcases diagnostic innovations at a dynamic exposition. The conference covers a range of timely topics from infectious diseases to big data to prenatal emerging technology\, as well as core laboratory areas in sample transport\, lab management\, and quality assurance. Each session is presented by experts in AACC’s scientific leadership. \nThis event is designed for physicians\, lab supervisors\, lab directors (and/or assistant directors)\, lab managers (supervisory and/or non-supervisory)\, medical technologists\, pathologists\, immunologists\, fellows\, residents\, in-training individuals\, and other healthcare professionals interested in laboratory medicine. \nPlease visit the AACC Middle East 2022 website for more information.
URL:https://globalbiodefense.com/event/aacc-middle-east/
LOCATION:Grand Hyatt Dubai\, Riyadh Street\, Sheikh Rashid Road\, Dubai\, United Arab Emirates
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221109T083000
DTEND;TZID=America/New_York:20221109T161500
DTSTAMP:20220922T162918Z
CREATED:20220922T162826Z
LAST-MODIFIED:20220922T162918Z
UID:56465-1667982600-1668010500@globalbiodefense.com
SUMMARY:Considerations and Approaches for Obese Patient Populations in Drug Development Studies
DESCRIPTION:Obese patients are a large segment of the U.S. population and should be included in medical countermeasure and drug development studies. There are presently no clear dosing guidelines for obese pediatric patients. \nThe U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a one-day virtual public workshop entitled “Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches” on November 9\, 2022. The purpose of this workshop is to review the implications of obesity in adult and pediatric patients on safety\, efficacy\, drug dosing and disposition. \nBesides the major health and socioeconomic implications of obesity\, there are great challenges in ensuring the optimal use and development of drugs for the growing population of obese persons. Obese patients are a large segment of the U.S. population and should be included in drug development studies. There are presently no clear dosing guidelines for obese pediatric patients. Although smaller clinical studies have begun to examine drug pharmacokinetics in obese pediatric patients\, the relationship between pediatric obesity and drug response\, including efficacy and safety\, has not been thoroughly elucidated. Advancing this field requires identifying key knowledge gaps and barriers to the conduct of such studies and potential innovative solutions to improve data generation and analysis. \nThe workshop aims to: \n\nReview the implications of obesity in adult and pediatric patients on safety\, efficacy\, drug dosing and disposition.\nDiscuss whether adult and pediatric patients should be identified and studied as a special population in new drug development programs\nAddress when it may be appropriate to include obese patients in drug development studies to develop specific dosing guidelines for obese patients\n\nThe workshop which is jointly sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA\, will be open to the public. \nPlease visit the FDA’s Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches event page for more information.
URL:https://globalbiodefense.com/event/considerations-and-approaches-for-obese-patient-populations-in-drug-development-studies/
CATEGORIES:Government Hosted,Workshop
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221109T090000
DTEND;TZID=America/New_York:20221109T170000
DTSTAMP:20220922T161453Z
CREATED:20220922T161453Z
LAST-MODIFIED:20220922T161453Z
UID:56463-1667984400-1668013200@globalbiodefense.com
SUMMARY:FDA Review: EUA for Oral Sabizabulin for High-Risk COVID-19 Patients
DESCRIPTION:The FDA’s Pulmonary-Allergy Drugs Advisory Committee Meeting will convene on 9 November 2022 to discuss the request for Emergency Use Authorization (EUA) for sabizabulin oral capsule\, a tubulin polymerization inhibitor\, submitted by Veru Inc.\, for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome. \nSabizabulin is an oral\, novel microtubule disruptor that has dual antiviral and anti-inflammatory activities in preclinical models. \nA focus of the discussion will include the treatment effect size in the context of the high placebo mortality rate\, the limited size of the safety database\, and identifying the proposed population. \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-2107. \nPlease visit the FDA’s Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement for more information.
URL:https://globalbiodefense.com/event/fda-review-eua-for-oral-sabizabulin-for-high-risk-covid-19-patients/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221111
DTEND;VALUE=DATE:20221118
DTSTAMP:20220620T202418Z
CREATED:20220620T202418Z
LAST-MODIFIED:20220620T202418Z
UID:55678-1668124800-1668729599@globalbiodefense.com
SUMMARY:70th IAEM Annual Conference & EMEX
DESCRIPTION:The 70th IAEM Annual Conference & EMEX will be held 11-17 November 2022 in Savannah\, Georgia. \nThe program features more than 150 speakers providing plenaries and breakout sessions under the umbrella theme\, “Emergency Management Unmuted.” In addition\, All DHS/FEMA pre-/post-conference training courses\, the IAEM Leadership Symposium\, IAEM K-12 Workshop\, and the Ascenttra Advanced Exercise Design Course are complimentary for those registered under the full and student registration rates. \nHighlighted topics\, sessions and courses include: \n\nIntermediate Incident Command System for Expanding Incidents\nEvolving NIMS to Protect Information and Technology and Communications Used at Ad-hoc and Temporary Vaccination and Hospital Sites\nLeadership Symposium: Preparing for Disaster Resilience\nCERT Worldwide: The State of Disaster Volunteerism in Latin America\nAn Examination of Current Requirements for Expansion of Nuclear Emergency Support Teams (NEST)\nErosion of Trust: Impacts of Mis and Dis Information to Emergency Management\nHealthcare Caucus Emergency Managers Symposium: Collaborating for the Future\nEmbedding Meteorologists into Emergency Operations\nEvidence-Building in Emergency Management: Expanding Efforts to Measure the Effectiveness of Preparedness Investments\nHomeland Security Exercise and Evaluation Program Training Course\nCrisis Leadership and Decision Making\nAfter the Rumbling Stops … Initiating “Unmuted” Transportation Disaster Response\nK-12 Pre Conference Workshop – Resilient Communities\nEmergency Management during Political Unrest: Lessons from International Medical Organizations and Anecdotes from Yemen\, Syria\, and Afghanistan\nIntroduction to Disaster Recovery Public Assistance Programs\nStrengthening County (Local) Tactical Emergency Animal Shelter Plans: Collaboration Between Texas A and M VET and County EM Coordinators\nMitigation Assessment Team (MAT) Workshop\nUniv. and Colleges E.M. Practitioners Symposium\nRe-Imagining Emergency Response for Children and Families\nCommunity Preparedness for Cyber Incidents\nAEM / CEM Preparatory Course\n\nLearn more and register online at the IAEM Annual Conference website.
URL:https://globalbiodefense.com/event/70th-iaem-annual-conference-emex/
LOCATION:Savannah International Trade and Convention Center\, 1 International Drive \, Savannah\, GA\, 31402\, United States
CATEGORIES:Conference
END:VEVENT
END:VCALENDAR