BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Global Biodefense - ECPv6.18.0//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-ORIGINAL-URL:https://globalbiodefense.com
X-WR-CALDESC:Events for Global Biodefense
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20210314T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20211107T060000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20220313T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20221106T060000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20230312T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20231105T060000
END:STANDARD
END:VTIMEZONE
BEGIN: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: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
END:VCALENDAR