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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/
LOCATION:
CATEGORIES:Government Hosted
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/
LOCATION:
CATEGORIES:Government Hosted,Webinar-Webcast
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/
LOCATION:https://youtu.be/qazitJMHZK4
CATEGORIES:Government Hosted
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/
LOCATION:
CATEGORIES:Continuing Education,Government Hosted
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/
LOCATION:
CATEGORIES:Webinar-Webcast
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/
LOCATION:https://fda.zoomgov.com/webinar/register/WN_LKO4FXAlSfSuP89383sikg
CATEGORIES:Government Hosted
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/
LOCATION:DE
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/
LOCATION:
CATEGORIES:Government Hosted,Webinar-Webcast
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/
LOCATION:
CATEGORIES:Continuing Education,Government Hosted
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/
LOCATION:
CATEGORIES:Webinar-Webcast
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/
LOCATION:https://umaryland.zoom.us/webinar/register/WN_QLkZn5TbTYqu4F986aKD6g
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
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/
LOCATION:https://us02web.zoom.us/webinar/register/1316650817717/WN_273HybPhTfOA1Df_brsQNQ
CATEGORIES:Conference,Webinar-Webcast
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/
LOCATION:
CATEGORIES:Government Hosted,Webinar-Webcast
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/
LOCATION:
CATEGORIES:Government Hosted,Workshop
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/
LOCATION:
CATEGORIES:Government Hosted
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
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221114
DTEND;VALUE=DATE:20221117
DTSTAMP:20220922T160410Z
CREATED:20220922T160410Z
LAST-MODIFIED:20220922T160410Z
UID:56460-1668384000-1668643199@globalbiodefense.com
SUMMARY:Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing
DESCRIPTION:The FDA and Product Quality Research Institute (PQRI) will host a webcast workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing on 14-16 November 2022. \nFuture pharmaceutical manufacturing may occur not only in large manufacturing facilities; it may occur in smaller\, more geographically distributed facilities or even at the point of care. The National Academies of Sciences\, Engineering\, and Medicine noted in a 2021 report that FDA is likely to see substantial innovations in integrated\, flexible\, and distributed manufacturing (DM). These innovations include modular approaches to streamline drug and biologic production and the deployment and use of highly portable manufacturing units that could enable point of care (POC) manufacturing. These types of technologies may challenge the traditional approaches to regulating pharmaceutical manufacturing. \nFDA has also encountered the rapid emergence of advanced manufacturing technologies in various investigational biological products\, such as tissue-based\, cell and gene advanced therapy products\, intersecting with critical areas associated with DM and POC manufacturing. Such biologics are generally more complex with undefined critical quality attributes and often have different manufacturing paradigms. This is particularly true for cellular and gene therapy products and tissue-engineered products. \nThe Workshop aims to facilitate interaction among DM/POC stakeholders on critical areas for development and implementation of these technologies including terminology\, technical challenges to adoption\, operation of Pharmaceutical Quality Systems\, good manufacturing practice expectations\, and the unique challenges and considerations that apply to complex biologics. \nPlease visit PQRI’s Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing website for more information. \n 
URL:https://globalbiodefense.com/event/regulatory-framework-for-distributed-and-point-of-care-pharmaceutical-manufacturing/
LOCATION:
CATEGORIES:Webinar-Webcast,Workshop
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221115
DTEND;VALUE=DATE:20221117
DTSTAMP:20220621T165636Z
CREATED:20220621T164935Z
LAST-MODIFIED:20220621T165636Z
UID:55684-1668470400-1668643199@globalbiodefense.com
SUMMARY:BARDA Industry Day 2022 - BID22
DESCRIPTION:The Biomedical Advanced Research and Development Authority (BARDA) 2022 Industry Day virtual event will be held 15-16 November 2022. \nBARDA\, a component of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR)\, invites you to participate in the annual conference to learn about U.S. Government medical countermeasure priorities\, interact with the BARDA and ASPR teams\, and network with public and private sector colleagues. \nThis year’s lineup will have an assortment of BARDA program briefings\, featured speakers\, special sessions\, and breakout sessions addressing efforts towards four strategic goals of enhancing preparedness\, response\, and partnerships against future threats. There will be a renewed focus on strengthening connections\, networking\, and collaboration within the virtual event environment. \n \nAt last year’s BARDA Industry Day event\, BARDA Director Dr. Gary Disbrow delivered a strategic overview of BARDA’s mission\, priorities and engagement during welcoming remarks. \nPlease visit the BARDA website for the latest updates.
URL:https://globalbiodefense.com/event/barda-industry-day-2022-bid22/
LOCATION:
CATEGORIES:Government Hosted
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/06/barda-industry-day-2022-bid-november.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221118
DTEND;VALUE=DATE:20221125
DTSTAMP:20220927T152319Z
CREATED:20220927T145825Z
LAST-MODIFIED:20220927T152319Z
UID:56526-1668729600-1669334399@globalbiodefense.com
SUMMARY:Antimicrobial Awareness Week
DESCRIPTION:The World Antimicrobial Awareness Week and U.S. Antibiotic Awareness Week take place 18-24 November 2022.\n \nAntimicrobial resistance (AMR) occurs when bacteria\, viruses\, fungi and parasites change over time and no longer respond to medicines\, making infections harder to treat and increasing the risk of disease spread\, severe illness and death. As a result of drug resistance\, antibiotics and other antimicrobial medicines become ineffective and infections become increasingly difficult or impossible to treat. Researchers estimated that AMR in bacteria caused an estimated 1.27 million deaths in 20191. \nA global action plan to tackle the growing problem of resistance to antibiotics and other antimicrobial medicines was endorsed at the Sixty-eighth World Health Assembly in May 2015. One of the key objectives of the plan is to improve awareness and understanding of AMR through effective communication\, education and training. \nWorld Antimicrobial Awareness Week (WAAW) is a global campaign that is celebrated annually to improve awareness and understanding of AMR and encourage best practices among the public\, One Health stakeholders and policymakers\, who all play a critical role in reducing the further emergence and spread of AMR. \nThis year\, the theme of WAAW is “Preventing Antimicrobial Resistance Together.” We call on all sectors to encourage the prudent use of antimicrobials and to strengthen preventive measures addressing AMR\, working together collaboratively through a One Health approach. \nU.S. Antibiotic Awareness Week is an annual one-week observance coinciding with the global awareness effort that gives participating organizations an opportunity to raise awareness of the importance of appropriate antibiotic use to combat the threat of antibiotic resistance. \n… \n…Resources from the U.S. CDC \n\nHealthcare Professionals: Remind your patients that antibiotics are only needed to treat certain infections caused by bacteria\, not viruses like those that cause COVID-19. https://bit.ly/3k6EfOe\nHCPs: Be antibiotics aware by telling patients why they don’t need antibiotics for a virus. https://bit.ly/3BRx1pl\nHealthcare Professionals: Protect your patients. Remember to prescribe the right antibiotic\, at the right dose\, for the right duration\, and at the right time. https://bit.ly/3k6EfOe\nHealthcare Professionals: Talk to your patients about when antibiotics are and aren’t needed\, and discuss possible side effects such as C. diff\, allergic reactions\, and antibiotic-resistant infections. CDC has resources to help you educate your patients. https://bit.ly/3BRx1pl\n\nTwitter\n\n#Antibiotics aren’t needed for and won’t help treat colds\, #flu\, or #COVID19. #BeAntibioticsAware and talk to your #HCP: https://bit.ly/3l8KFyd #USAAW21\nBeing #antibiotics aware = knowing that antibiotics aren’t needed for many #sinus infections and some ear #infections. https://bit.ly/3rKkb7M #BeAntibioticsAware #USAAW21\nDuring U.S. #AntibioticAwareness Week\, #BeAntibioticsAware and learn when #antibiotics are needed and when they’re not. https://bit.ly/3l8KFyd #USAAW21\nWhen #antibiotics aren’t needed\, they won’t help you\, and the side effects could still cause harm. Learn more. https://bit.ly/3l8KFyd #BeAntibioticsAware #USAAW21\nTaking #antibiotics only when needed is one thing you can do to help fight #antibioticresistance. https://bit.ly/3laEVnM #USAAW21 #BeAntibioticsAware\nAnytime #antibiotics are used\, they can cause side effects and lead to #AntibioticResistance. #BeAntibioticsAware! https://bit.ly/3l8KFyd #USAAW21\nWe’re proud to be a #BeAntibioticsAware partner for U.S. Antibiotic Awareness Week! Learn how you can participate: https://bit.ly/3042qDw#USAAW21\n\nAntibiotics Quiz\n\nBe an antibiotics whiz. Test your knowledge about antibiotics.\n\nSepsis Resources\n\nGet Ahead of Sepsis educational effort\n\nStewardship Report\n\nCurrent Report: Antibiotic Use in the United States: Progress and Opportunities\nPast Antibiotic Prescribing and Use Reports\n\nCore Elements\n\nThe Core Elements of Outpatient Antibiotic Stewardship\nThe Core Elements of Hospital Antibiotic Stewardship Programs\nThe Core Elements of Antibiotic Stewardship at Small and Critical Access Hospitals \nThe Core Elements of Antibiotic Stewardship for Nursing Homes\nThe Core Elements of Human Antibiotic Stewardship Programs in Resource-Limited Settings [PDF – 28 pages]\n\nSpanish Resources\nInformation for patients on antibiotic use and resistance in Spanish (Recursos educativos para pacientes y profesionales de atención médica.) \nAntibiotic Stewardship Training\nThis interactive web-based activity contains four sections designed to help physicians optimize antibiotic use to combat antibiotic resistance and improve healthcare quality and patient safety. \nCDC’s Antibiotic Stewardship Training Series \nInformation on specific topics related to antibiotic resistance\n\nAntibiotic Resistance\nAntibiotic Resistance Questions and Answers\nAntibiotic Resistance and Food Safety\nAntibiotic-resistant Gonorrhea\nAntibiotic-resistant Tuberculosis\n\nSources: World Health Organization\, Centers for Disease Control and Prevention\, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)\, Division of Healthcare Quality Promotion (DHQP)
URL:https://globalbiodefense.com/event/antimicrobial-awareness-week/
LOCATION:
CATEGORIES:Awareness Event
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/09/antimicrobial-awareness-hand-hygiene.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221206T100000
DTEND;TZID=America/New_York:20221206T170000
DTSTAMP:20220921T172133Z
CREATED:20220921T171951Z
LAST-MODIFIED:20220921T172133Z
UID:56410-1670320800-1670346000@globalbiodefense.com
SUMMARY:FDA BAA Industry Day 2022
DESCRIPTION:The U.S. Food and Drug Administration FDA will host an Industry Day on 6 December 2022 to discuss a Broad Agency Announcement (BAA) for state of the art advancements in technology\, materials\, processes\, methods\, devices\, and techniques in pharmaceutical regulatory science. \nFDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Join the event to learn more about the FY 2023 BAA\, and how to apply. \nThe FDA BAA Industry Day 2022 will be held in virtual webcast format and is open to all responsible sources. Small businesses are strongly encouraged to participate. BAA Offerors may include single entities or teams from private sector organizations\, Federally Funded Research and Development Centers (FFRDCs)\, and academic institutions. \nThe FY 2023 FDA BAA has not yet been released at the time of this event listing (21 Sep 22). The FY 2022 FDA BAA is available here for reference.
URL:https://globalbiodefense.com/event/fda-baa-industry-day-2022/
LOCATION:
CATEGORIES:Government Hosted,Industry Day
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/09/fda-baa-2022-industry-day-broad-agency-announcement.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230228
DTEND;VALUE=DATE:20230303
DTSTAMP:20220923T211707Z
CREATED:20220923T211226Z
LAST-MODIFIED:20220923T211707Z
UID:56499-1677542400-1677801599@globalbiodefense.com
SUMMARY:2023 AHEPP Annual Conference
DESCRIPTION:The Association of Healthcare Emergency Preparedness Professionals will convene for the 2023 AHEPP Annual Conference in Scottsdale\, AZ from March 1 & 2\, 2023 and pre-conference on 28 February. \nThis event is dedicated to advancing emergency preparedness in healthcare facilities\, and specifically focuses on providing the latest research\, education\, and connections. \nExample topics and sessions include: \n\nCommand\, COVID and Cyberattacks: The Successful Implementation of an Evidence-Based EM Program and Health Response at Sanford Health\nConducting Integrated Full-Scale Disaster Exercises\nThe Changing Landscape of Pediatric Disaster Preparedness\nChallenges in Preparing and Responding to a Nuclear Disaster\nDisaster Echoes: Preventing Lessons Learned\nThe CALM System: Moving Decision Makers in the Zone\nAsking Critical Questions: How to Create Space for Ethical Discussions in Emergency Response\nClimate Change Resilience and Healthcare System Considerations\nSuccessful Command Center Redesign\nContingency Planning for Alternate Care Sites: Best Practices from Multi-Hospital Experiences in Decompressing Medical Surge from Covid\n\nPlease visit the AHEPP Annual Conference 2023 website for more information.
URL:https://globalbiodefense.com/event/ahepp-association-of-healthcare-emergency-preparedness-professionals/
LOCATION:Doubletree Resort by Hilton Paradise Valley\, 5401 N Scottsdale Rd\, Scottsdale\, AZ
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230306
DTEND;VALUE=DATE:20230309
DTSTAMP:20220208T205747Z
CREATED:20210925T003746Z
LAST-MODIFIED:20220208T205747Z
UID:49804-1678060800-1678319999@globalbiodefense.com
SUMMARY:Third International Summit on Human Genome Editing
DESCRIPTION:The Third International Summit on Human Genome Editing will be held March 6-8\, 2023 in London\, UK. \nThe event is being organized as a collaborative activity of the U.S. National Academy of Sciences and the U.S. National Academy of Medicine\, the U.K.’s Royal Society and Academy of Medical Sciences\, and The World Academy of Sciences.  It will bring together leading experts to examine the potential risks and benefits of genome editing technologies and the significant ethical and societal issues associated with advances in human genome editing research. \nThe Summit also address the recent report from the International Commission on the Clinical use of Heritable Human Genome Editing and the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing report. \nFurther information and details on how to access the Summit will be released closer to the time.
URL:https://globalbiodefense.com/event/third-international-summit-on-human-genome-editing/
LOCATION:Crick Institute\, 1 Midland Road\, London\, NW1 1AT\, United Kingdom
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230315
DTEND;VALUE=DATE:20230318
DTSTAMP:20221007T145216Z
CREATED:20221007T145024Z
LAST-MODIFIED:20221007T145216Z
UID:56539-1678838400-1679097599@globalbiodefense.com
SUMMARY:2023 ASPPH Annual Meeting
DESCRIPTION:The Association of Schools and Programs of Public Health will convene the 2023 ASPPH Annual Meeting from 15-17 March 2023 in Arlington\, Virginia. \nThis event convenes academic public health leaders\, faculty\, students\, and members of the public health community from around the world to engage in discussions and share new strategies and tools to strengthen education\, practice\, and research in public health. \nCall for Proposals\nASPPH seeks submissions for innovative ideas\, promising and emerging practices\, practical solutions\, and experiences in addressing challenges and opportunities in academic public health. The call for proposals is open until Monday\, November 14 at 11:59 PM PT. \nHighlighted submission topic areas include: \n\nEffective Communications Campaigns in Public Health Among Academia\nCreating and Sustaining Innovative Partnerships with Public Health Practice\nHow Schools and Programs of Public Health are Combatting Misinformation and Disinformation\nSupporting Continuing Professional Education and Professional Development for the Public Health Workforce\nMigration\, Climate Change\, and Global Health\nGlobal Student Experiences in a Hybrid World\nIncentivizing Research – Financial Models to Build and Grow Research with Non-Grant Funds\nInnovative Solutions with Remote Work: Faculty and Staff\nPromising Practices for Developing Competencies in Innovation\, Data Analytics\, and Forecasting\nSupporting Wellbeing and Physical and Mental Health in the Workforce\nPhD Funding Models – Cross-collaboration between Finance and Student Services\nLessons Learned from Integrating the Traditional Core MPH Requirements\nLeveraging Social Media in Public Health Communications\nDismantling Structural Racism in Academic Public Health: Case Examples\nRecruiting and Retaining a Diverse Public Health Workforce\n\nPlease visit the 2023 ASPPH Annual Conference website for more details.
URL:https://globalbiodefense.com/event/2023-aspph-annual-meeting/
LOCATION:Arlington\, VA\, Arlington\, VA
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230425
DTEND;VALUE=DATE:20230427
DTSTAMP:20230421T193514Z
CREATED:20230421T174138Z
LAST-MODIFIED:20230421T193514Z
UID:56972-1682380800-1682553599@globalbiodefense.com
SUMMARY:APEC Medical Product Supply Chain Resilience Dialogue
DESCRIPTION:FDA and United States Pharmacopeia (USP) are cosponsoring the Asia-Pacific Economic Cooperation (APEC) Medical Product Supply Chain Dialogue. This program aims to accelerate APEC and global efforts to strengthen the resilience of global medical product supply chains. This meeting will bring international medical product regulators\, multilateral organization representatives\, and industry and academic professionals together\, to discuss public health priorities\, the impact of the COVID-19 pandemic on supply chains\, and why the APEC Supply Chain Security ToolkitExternal Link Disclaimer continues to be a valuable tool to stakeholders. \nThis event is open to the public and free of cost. \nTopics will include: \n\nAPEC Roadmap to promote global medical product quality and supply chain security\nIdentifying vulnerabilities in the upstream supply chain\nMitigating and managing risks in raw material quality and supply chain security\nManufacturing solutions to strengthen global supply chain resilience\nExperiences strengthening quality assurance in the Asia Pacific\nSafeguarding patients from impurities in the drug supply chain\nThe supply chain imperative to fight AMR\nSecuring the downstream supply chain – good distribution practices & post-marketing surveillance\nSecuring the downstream supply chain – internet pharmacies\n\nPlease visit the APEC Medical Product Supply Chain Dialogue event website to register.
URL:https://globalbiodefense.com/event/apec-medical-product-supply-chain-resilience-dialogue/
LOCATION:USP Rockville\, 12601 Twinbrook Parkway\, Rockville\, MD\, 20852\, United States
CATEGORIES:Conference,Government Hosted
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2023/04/apec-medical-supply-chain-resilience.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230425T100000
DTEND;TZID=America/New_York:20230425T160000
DTSTAMP:20230421T193453Z
CREATED:20230421T165040Z
LAST-MODIFIED:20230421T193453Z
UID:56968-1682416800-1682438400@globalbiodefense.com
SUMMARY:FDA Public Meeting on Patient-Focused Drug Development for Long COVID
DESCRIPTION:The U.S. Food and Drug Administration (FDA) is hosting a virtual public meeting  25 April 2023 on Patient-Focused Drug Development for Long COVID. \nThis meeting will provide FDA the opportunity to obtain initial patient and patient representative input on the aspects of Long COVID\, including how Long COVID affects their daily life\, symptoms that matter most to patients\, their current approaches to treating Long COVID\, and what they consider when determining whether or not to participate in a clinical trial. \nThis virtual public meeting will be conducted with live translation in both English and Spanish. \nFDA encourages participants to submit written comments to the public docket by 26 June 2023: https://www.regulations.gov/document/FDA-2023-N-0363-0001 or visit www.regulations.gov and search for FDA-2023-N-0363-0001. \nPlease visit the U.S. FDA Meeting Information page for more information and Register here for the Meeting on Patient-Focused Drug Development for Long COVID. \n\nPublic Meeting on Patient-Focused Drug Development for Long COVIDDISCUSSION QUESTIONS\nTopic 1: Health effects and daily impacts that matter most to patients\n1. Which symptoms of Long COVID have the most significant impact on your life? (Examples may include pain\, difficulty thinking\, fatigue\, heart palpitations\, recurring blood clots\, depression\, or anxiety). \n2. Are there specific activities that are important to you that you cannot do at all or as fully as you would like because of your Long COVID? (Examples may include reading\, sleeping\, or exercising). \na. Is there a particular impact of Long COVID (such as need to work a reduced work schedule\, inability to complete daily tasks\, anxiety\, or depression) that worries you? If so\, what worries you most? \n3. How has your Long COVID changed from original diagnosis to now (have you noticed differences in severity\, change in symptoms)? \nTopic 2: Patients’ perspectives on current approaches to treatment\n1. What are you currently doing to treat or manage your Long COVID? (Examples may include prescription medicines\, over-the-counter products\, nutritional supplements\, and other therapies including non-drug therapies such as pulmonary rehabilitation\, aerobic exercises\, or diet modifications). \na. Has your treatment regimen changed over time\, and why? \nb. What factors went into your decision making when it came to selecting a course of management for your Long COVID? \n2. Would you say your Long COVID today is well-managed? Please explain. \n3. Assuming there is no complete cure for your Long COVID\, what specific things would you look for in an ideal treatment for your Long COVID? \na. Is there a particular symptom of Long COVID (such as fatigue\, brain fog\, or loss of sense of smell/taste) that you would prioritize for treatment? If so\, which symptom would you prioritize? \nb. What would you consider a successful treatment outcome? \nTopic 3: Patients’ perspectives on clinical trials for Long COVID\n1. If you considered participating or have participated in a clinical trial for Long COVID\, please tell us about your experience. \na. What factors (if any) of the clinical trial enabled you to participate? \nb. What factors (if any) of the clinical trial made it more difficult for you to participate? \n2. How would the following factors weigh into your decision if you were considering participating in a clinical trial? \na. The clinical trial intervention (Examples may include side effects of the medical intervention\, how the intervention is administered etc.). \nb. The logistics of the clinical trial (Examples may include the duration of the trial\, whether the trial is fully remote or requires clinic visits\, the number of in-person clinic visits required\, distance from home to clinic site\, or whether you might receive a placebo or not). \n3. What outcomes for Long COVID are most important to measure in a trial setting? (Examples may include reduction in pain\, brain fog\, fatigue\, or other aspects; or improvement in your ability to perform daily activities such as reading\, sleeping\, or exercising)
URL:https://globalbiodefense.com/event/fda-public-meeting-on-patient-focused-drug-development-for-long-covid/
LOCATION:
CATEGORIES:Government Hosted
END:VEVENT
END:VCALENDAR