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X-WR-CALDESC:Events for Global Biodefense
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DTSTART:20220101T000000
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20221019
DTEND;VALUE=DATE:20221022
DTSTAMP:20220922T140954Z
CREATED:20220922T140800Z
LAST-MODIFIED:20220922T140954Z
UID:56448-1666137600-1666396799@globalbiodefense.com
SUMMARY:GSRS22 - 12th Global Summit on Regulatory Science
DESCRIPTION:GSRS22: The 12th Global Summit on Regulatory Science will be held from 19-21 October 2022 in Singapore. \nConvening under a theme of “Advances in Nanotechnology for Food and Medical Products: Innovations\, Safety and Standards”. the Summit will highlight topics including: \n\nNanomaterials for Gene Delivery\nNanotechnology in Agri-Products\nEmerging Nanomaterial Contaminants in Food\nGeneric Medical Products Containing Nanomaterial\nRole of Nanotechnology in Precision Medicine\nInnovation in Nanotechnology for Food\n\nThe Global Summit is free to attend\, but registration is required to attend the conference. \nThis event is being co-hosted by Singapore Food Agency (SFA) and the Global Coalition for Regulatory Science Research (GCRSR). \nPlease visit the GSRS22 website to register.
URL:https://globalbiodefense.com/event/gsrs22-12th-global-summit-on-regulatory-science/
LOCATION:Orchard Hotel Singapore\, 442 Orchard Road\, Singapore\, 238879\, Singapore
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221019T093000
DTEND;TZID=America/New_York:20221019T123000
DTSTAMP:20220922T190024Z
CREATED:20220922T185728Z
LAST-MODIFIED:20220922T190024Z
UID:56475-1666171800-1666182600@globalbiodefense.com
SUMMARY:CBRN Threats and Challenges - Fall Quarterly Update
DESCRIPTION:The NDIA will host a CBRN Threats and Challenges Fall Quarterly Update Forum on 19 October 2022. \nThis quarterly meeting is set to provide a SECRET-level classified update from government representatives in the Chemical and Biological Defense Program (CBDP). This update will inform industry and government attendees about the CB Threat concerns that the DASD is focused on and highlight the priority efforts to address those threats. The objective is to improve understanding across the community and help them to focus their efforts and resources in ways that align to the CBDP’s priorities. \nSpeakers include \n\nIan Watson\, Deputy ASD for Chemical and Biological Defense\nDarryl Colvin\, JPEO CBRND\n\nThis is a classified event. \nPlease visit NDIA’s CBRN Threats and Challenges – A Classified Update event page for more information.
URL:https://globalbiodefense.com/event/cbrn-threats-and-challenges-fall-quarterly-update/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221024T110000
DTEND;TZID=America/New_York:20221024T172000
DTSTAMP:20220905T180114Z
CREATED:20220905T180114Z
LAST-MODIFIED:20220905T180114Z
UID:56285-1666609200-1666632000@globalbiodefense.com
SUMMARY:Board of Scientific Counselors\, National Center for Health Statistics
DESCRIPTION:The CDC has announced the Board of Scientific Counselors\, National Center for Health Statistics (BSC\, NCHS) will convene 24 October 2022 in a live broadcast public meeting. \nThe Board is charged with providing advice and making recommendations to the Secretary\, Department of Health and Human Services; the Director\, CDC; and the Director\, NCHS\, regarding the scientific and technical program goals and objectives\, strategies\, and priorities of NCHS. \nThe meeting agenda will include a Center update by the NCHS Director in addition to updates on NCHS data collection\, analysis\, and reporting activities\, including upcoming changes to the National Hospital Ambulatory Medical Care Survey (NHAMCS); status of a National Ambulatory Medical Care Survey (NAMCS) pilot and plans for obtaining clinician visit data; a new project to improve metadata and catalogs for the public to access restricted use data files; and new releases of linked data sets. The Board’s Workgroup to Consider and Assess Measures of Discrimination for Use in NCHS Surveys will brief the Board with findings from 6 months of information-gathering and assessment work. The Committee will reserve time for public comment at the end of the day. Meeting times and topics are subject to change as priorities dictate. \nMeeting Information: Please visit the BSC\, NCHS website for details. Further information and the meeting agenda will be available on the BSC website\, including instructions for accessing the live meeting broadcast.
URL:https://globalbiodefense.com/event/board-of-scientific-counselors-national-center-for-health-statistics/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221026
DTEND;VALUE=DATE:20221027
DTSTAMP:20220921T211348Z
CREATED:20220921T211237Z
LAST-MODIFIED:20220921T211348Z
UID:56442-1666742400-1666828799@globalbiodefense.com
SUMMARY:In-Depth Look at Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs
DESCRIPTION:The FDA will host a meeting on 26 October 2022 to provide additional clarity to the final guidance with respect to Agency expectations for submissions containing Bioavailability information for drug products\, and will discuss: \n\nSelect case studies on various bioavailability (BA) related subtopics (e.g. pharmacodynamic (PD) endpoints\, endogenous compound Narrow Therapeutic Index (NTI)\, biowaivers).\nBioavailability Studies Submitted in NDAs and INDs – General Considerations\nBioavailability Determination: Special Topics\nRelative Bioavailability Evaluation: Potential for Using Pharmacodynamic and Non-Traditional Pharmacokinetic Endpoints\nRecommended In Vitro Studies\n\nThe intended audience for this event is: Regulatory Scientists assessing bioavailability studies as part of IND/NDA/BLA submissions; Research Coordinators overseeing in vivo studies in the context of IND/NDA/BLA submissions; Drug Development/New Drug industry scientists involved with bioavailability studies for support of a new/existing IND/NDA/BLA dossier; and foreign regulators. \nPlease visit the FDA’s In-Depth Look at BA Final Guidance Meeting website to register. \nFDA RESOURCES\nFinal Guidance for Industry: Bioavailability Studies Submitted in NDAs or INDs — General Considerations
URL:https://globalbiodefense.com/event/in-depth-look-at-final-fda-guidance-bioavailability-studies-submitted-in-ndas-or-inds/
CATEGORIES:Continuing Education,Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221026T140000
DTEND;TZID=America/New_York:20221026T150000
DTSTAMP:20221007T143637Z
CREATED:20221007T143454Z
LAST-MODIFIED:20221007T143637Z
UID:56536-1666792800-1666796400@globalbiodefense.com
SUMMARY:Responding to the Climate Change and Health Crisis: A Framework for Academic Public Health
DESCRIPTION:The Association of Schools and Programs of Public Health (ASPPH) will host a framework launch webinar on Responding to the Climate Change and Health Crisis from 2:00 – 3:00 PM ET on Wednesday\, October 26\, featuring an expert panel that will discuss some of the challenges and opportunities it identifies. \nThe framework examines climate change and health in four primary domains – Education and Training\, Research\, Practice\, and Policy and Advocacy – and considers three cross-cutting themes: Environmental Justice\, Social Justice\, and Health Equity; Interprofessional and Interdisciplinary Collaborations; and Partnerships for Impact. The framework concludes with a set of evidence-based principles and recommendations – for both schools and programs of public health (SPPH) and ASPPH as a whole – to take collective action and work with vested partners to reduce the impacts of climate change on population health. \nThe framework was developed by the ASPPH Task Force on Climate Change and Health\, comprised of experts in a range of climate change and health-related topics from across our member schools and programs\, with feedback from members and partners. In conjunction\, we are also releasing ASPPH’s statement of commitment to addressing climate change and health. \nPlease visit ASPPH for more information.
URL:https://globalbiodefense.com/event/responding-to-the-climate-change-and-health-crisis-framework-for-academic-public-health/
CATEGORIES:Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221027
DTEND;VALUE=DATE:20221029
DTSTAMP:20220921T222128Z
CREATED:20220921T222128Z
LAST-MODIFIED:20220921T222128Z
UID:56444-1666828800-1667001599@globalbiodefense.com
SUMMARY:Best Practices: Modeling Approaches to Support Generic Product Development
DESCRIPTION:FDA and the Center for Research on Complex Generics (CRCG) will host a free public workshop on October 27-28\, 2022: Best Practices for Utilizing Modeling Approaches to Support Generic Product Development \nThe purpose of this two-day workshop is to discuss and illustrate how generic product developers can utilize modeling approaches in conjunction with in vitro data and other knowledge to support the development of complex generics that may otherwise rely upon challenging in vivo studies to demonstrate bioequivalence. \nThis workshop will engage experts from regulatory agencies\, the generic drug industry\, consultants\, academia\, and others in the field of modeling and simulation to discuss the opportunities and best practices for incorporating modeling and simulation approaches into generic drug development programs and regulatory submissions. The workshop will also identify commonalities in methodologies/workflows or in silico models supporting alternative BE approaches and clarify how a model master file may be leveraged to advance drug product development\, facilitate regulatory assessment\, and streamline drug product approval. \nFDA and the CRCG—which is a collaboration between the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy—are dedicated to advancing programs that stimulate scientific dialogue\, disseminate current insights about complex generics\, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines. \nHighlighted topics include: \n\nUse of model integrated evidence to support demonstrations of BE in a regulatory context\nUse of the same or similar model or modeling strategy across multiple submissions related to complex drug products\nMechanistic modeling approaches supporting BE assessments for oral drug products\nApplications of quantitative comparative approaches to support the development of complex generic drug products\nCase examples supporting the recently introduced concept of “model master files”\n\nPlease visit the FDA’s Best Practices for Utilizing Modeling Approaches to Support Generic Product Development meeting page for information on registration.
URL:https://globalbiodefense.com/event/best-practices-modeling-approaches-to-support-generic-product-development/
CATEGORIES:Government Hosted,Webinar-Webcast
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/09/complex-genomics-modeling-approaches-generic-product-fda.jpg
LOCATION:https://umaryland.zoom.us/webinar/register/WN_QLkZn5TbTYqu4F986aKD6g
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221027T140000
DTEND;TZID=America/New_York:20221027T150000
DTSTAMP:20221025T173153Z
CREATED:20221025T173153Z
LAST-MODIFIED:20221025T173153Z
UID:56589-1666879200-1666882800@globalbiodefense.com
SUMMARY:Public Health Workforce Calculator: Staffing up to Achieve Foundational Services
DESCRIPTION:In 2021\, an analysis of the public health workforce found that state and local governmental public health departments need an 80% increase in their workforce to provide a minimum set of public health services to the nation. In response to this gap\, the Public Health National Center for Innovations at PHAB\, de Beaumont Foundation\, and the Centers for Disease Control and Prevention’s Center for State\, Tribal\, Local and Territorial Support developed the Public Health Workforce Calculator to aid local health departments in estimating staffing needs to provide the Foundational Public Health Services in their community. Join us on October 27th at 2PM ET to learn more about the Calculator and how it can contribute to workforce staffing needs and planning for public health funding. \nWebinar Objectives\n– Describe how the analysis was used to successfully build support for health departments\n– Explain the intended use of the recently released Public Health Workforce Calculator.\n– Demonstrate how to use the Calculator\, including identifying the Calculator’s best use cases.
URL:https://globalbiodefense.com/event/public-health-workforce-calculator-staffing-up-to-achieve-foundational-services/
CATEGORIES:Conference,Webinar-Webcast
LOCATION:https://us02web.zoom.us/webinar/register/1316650817717/WN_273HybPhTfOA1Df_brsQNQ
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221102
DTEND;VALUE=DATE:20221104
DTSTAMP:20220922T163745Z
CREATED:20220922T163745Z
LAST-MODIFIED:20220922T163745Z
UID:56469-1667347200-1667519999@globalbiodefense.com
SUMMARY:Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
DESCRIPTION:On November 2\, 2022\, the committee will discuss the Center for Drug Evaluation and Research (CDER) Quality Management Maturity (QMM) program. QMM is the state attained when drug manufacturers have consistent\, reliable\, and robust business processes to achieve quality objectives and promote continual improvement. CDER has proposed the development of a rating system that will help incentivize drug manufacturers to adopt more mature quality management practices at their facilities. The committee will consider the impact that a QMM program would have on the pharmaceutical industry\, drug shortages\, and supply chain resiliency. FDA will seek input to determine if experts from academia and industry support the development of a CDER QMM program to incentivize investments in mature quality management practices. \nOn November 3\, 2022\, as part of CDER’s continued effort to provide key updates on modernization of quality assessment\, the committee will discuss the next stages of Knowledge-Aided Assessment and Structured Application (KASA). The concept of KASA was envisioned in 2016 and discussed at the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting on September 20\, 2018\, as an IT system that modernizes FDA’s assessment. Through the development\, testing\, and implementation of various KASA prototypes\, the KASA system has been refined over the course of multiple years. FDA will seek input on the vision and plan to expand KASA over the next 5 years to include drug substances\, all generic dosage forms\, new drug and biologics applications\, and post-approval changes. Moreover\, FDA will seek input regarding the need for advancing digitalization in KASA\, including data standardization and mobilization of data from cloud-based servers. \nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2022-N-1777. \nPlease visit the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement page for more information.
URL:https://globalbiodefense.com/event/pharmaceutical-science-and-clinical-pharmacology-advisory-committee-meeting/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221105
DTEND;VALUE=DATE:20221107
DTSTAMP:20220923T191814Z
CREATED:20220923T191704Z
LAST-MODIFIED:20220923T191814Z
UID:56486-1667606400-1667779199@globalbiodefense.com
SUMMARY:AACC Middle East
DESCRIPTION:AACC Middle East will be held 5-6 November in Dubai\, UAE in partnership with Life Dx. The event that brings the latest in laboratory medicine to the Middle East region and showcases diagnostic innovations at a dynamic exposition. The conference covers a range of timely topics from infectious diseases to big data to prenatal emerging technology\, as well as core laboratory areas in sample transport\, lab management\, and quality assurance. Each session is presented by experts in AACC’s scientific leadership. \nThis event is designed for physicians\, lab supervisors\, lab directors (and/or assistant directors)\, lab managers (supervisory and/or non-supervisory)\, medical technologists\, pathologists\, immunologists\, fellows\, residents\, in-training individuals\, and other healthcare professionals interested in laboratory medicine. \nPlease visit the AACC Middle East 2022 website for more information.
URL:https://globalbiodefense.com/event/aacc-middle-east/
LOCATION:Grand Hyatt Dubai\, Riyadh Street\, Sheikh Rashid Road\, Dubai\, United Arab Emirates
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221109T083000
DTEND;TZID=America/New_York:20221109T161500
DTSTAMP:20220922T162918Z
CREATED:20220922T162826Z
LAST-MODIFIED:20220922T162918Z
UID:56465-1667982600-1668010500@globalbiodefense.com
SUMMARY:Considerations and Approaches for Obese Patient Populations in Drug Development Studies
DESCRIPTION:Obese patients are a large segment of the U.S. population and should be included in medical countermeasure and drug development studies. There are presently no clear dosing guidelines for obese pediatric patients. \nThe U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a one-day virtual public workshop entitled “Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches” on November 9\, 2022. The purpose of this workshop is to review the implications of obesity in adult and pediatric patients on safety\, efficacy\, drug dosing and disposition. \nBesides the major health and socioeconomic implications of obesity\, there are great challenges in ensuring the optimal use and development of drugs for the growing population of obese persons. Obese patients are a large segment of the U.S. population and should be included in drug development studies. There are presently no clear dosing guidelines for obese pediatric patients. Although smaller clinical studies have begun to examine drug pharmacokinetics in obese pediatric patients\, the relationship between pediatric obesity and drug response\, including efficacy and safety\, has not been thoroughly elucidated. Advancing this field requires identifying key knowledge gaps and barriers to the conduct of such studies and potential innovative solutions to improve data generation and analysis. \nThe workshop aims to: \n\nReview the implications of obesity in adult and pediatric patients on safety\, efficacy\, drug dosing and disposition.\nDiscuss whether adult and pediatric patients should be identified and studied as a special population in new drug development programs\nAddress when it may be appropriate to include obese patients in drug development studies to develop specific dosing guidelines for obese patients\n\nThe workshop which is jointly sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA\, will be open to the public. \nPlease visit the FDA’s Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches event page for more information.
URL:https://globalbiodefense.com/event/considerations-and-approaches-for-obese-patient-populations-in-drug-development-studies/
CATEGORIES:Government Hosted,Workshop
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221109T090000
DTEND;TZID=America/New_York:20221109T170000
DTSTAMP:20220922T161453Z
CREATED:20220922T161453Z
LAST-MODIFIED:20220922T161453Z
UID:56463-1667984400-1668013200@globalbiodefense.com
SUMMARY:FDA Review: EUA for Oral Sabizabulin for High-Risk COVID-19 Patients
DESCRIPTION:The FDA’s Pulmonary-Allergy Drugs Advisory Committee Meeting will convene on 9 November 2022 to discuss the request for Emergency Use Authorization (EUA) for sabizabulin oral capsule\, a tubulin polymerization inhibitor\, submitted by Veru Inc.\, for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome. \nSabizabulin is an oral\, novel microtubule disruptor that has dual antiviral and anti-inflammatory activities in preclinical models. \nA focus of the discussion will include the treatment effect size in the context of the high placebo mortality rate\, the limited size of the safety database\, and identifying the proposed population. \nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2022-N-2107. \nPlease visit the FDA’s Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement for more information.
URL:https://globalbiodefense.com/event/fda-review-eua-for-oral-sabizabulin-for-high-risk-covid-19-patients/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221111
DTEND;VALUE=DATE:20221118
DTSTAMP:20220620T202418Z
CREATED:20220620T202418Z
LAST-MODIFIED:20220620T202418Z
UID:55678-1668124800-1668729599@globalbiodefense.com
SUMMARY:70th IAEM Annual Conference & EMEX
DESCRIPTION:The 70th IAEM Annual Conference & EMEX will be held 11-17 November 2022 in Savannah\, Georgia. \nThe program features more than 150 speakers providing plenaries and breakout sessions under the umbrella theme\, “Emergency Management Unmuted.” In addition\, All DHS/FEMA pre-/post-conference training courses\, the IAEM Leadership Symposium\, IAEM K-12 Workshop\, and the Ascenttra Advanced Exercise Design Course are complimentary for those registered under the full and student registration rates. \nHighlighted topics\, sessions and courses include: \n\nIntermediate Incident Command System for Expanding Incidents\nEvolving NIMS to Protect Information and Technology and Communications Used at Ad-hoc and Temporary Vaccination and Hospital Sites\nLeadership Symposium: Preparing for Disaster Resilience\nCERT Worldwide: The State of Disaster Volunteerism in Latin America\nAn Examination of Current Requirements for Expansion of Nuclear Emergency Support Teams (NEST)\nErosion of Trust: Impacts of Mis and Dis Information to Emergency Management\nHealthcare Caucus Emergency Managers Symposium: Collaborating for the Future\nEmbedding Meteorologists into Emergency Operations\nEvidence-Building in Emergency Management: Expanding Efforts to Measure the Effectiveness of Preparedness Investments\nHomeland Security Exercise and Evaluation Program Training Course\nCrisis Leadership and Decision Making\nAfter the Rumbling Stops … Initiating “Unmuted” Transportation Disaster Response\nK-12 Pre Conference Workshop – Resilient Communities\nEmergency Management during Political Unrest: Lessons from International Medical Organizations and Anecdotes from Yemen\, Syria\, and Afghanistan\nIntroduction to Disaster Recovery Public Assistance Programs\nStrengthening County (Local) Tactical Emergency Animal Shelter Plans: Collaboration Between Texas A and M VET and County EM Coordinators\nMitigation Assessment Team (MAT) Workshop\nUniv. and Colleges E.M. Practitioners Symposium\nRe-Imagining Emergency Response for Children and Families\nCommunity Preparedness for Cyber Incidents\nAEM / CEM Preparatory Course\n\nLearn more and register online at the IAEM Annual Conference website.
URL:https://globalbiodefense.com/event/70th-iaem-annual-conference-emex/
LOCATION:Savannah International Trade and Convention Center\, 1 International Drive \, Savannah\, GA\, 31402\, United States
CATEGORIES:Conference
END:VEVENT
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/
CATEGORIES:Webinar-Webcast,Workshop
LOCATION:
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/
CATEGORIES:Government Hosted
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/06/barda-industry-day-2022-bid-november.jpg
LOCATION:
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/
CATEGORIES:Awareness Event
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/09/antimicrobial-awareness-hand-hygiene.jpg
LOCATION:
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/
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
LOCATION:
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/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230426T120500
DTEND;TZID=America/New_York:20230426T130000
DTSTAMP:20230421T193433Z
CREATED:20230421T180910Z
LAST-MODIFIED:20230421T193433Z
UID:56982-1682510700-1682514000@globalbiodefense.com
SUMMARY:Test Development and Validation During the COVID-19 Public Health Emergency
DESCRIPTION:The U.S. Food and Drug Administration (FDA) will host a virtual town hall on 26 April 2023 for test developers to discuss the final guidances for the: \n\nTransition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency\nTransition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)\n\nThe guidances outline the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations\, including the FDA’s recommendations for: \n\nDeveloping a transition implementation plan for in vitro diagnostics (IVDs) with an EUA\,\nSubmitting an IVD marketing submission\,\nTaking other actions with respect to these IVDs\, and\nAdditional information related to test developers and COVID-19 tests.\n\nNo registration is required. \nTime: 12:05 p.m. – 1 p.m. ET\nTo ensure you are connected\, please join 15 minutes before the start of the virtual town hall. \nPlease click the link below to join the webinar: \n\nhttps://fda.zoomgov.com/j/1612083563?pwd=NklWOE1jUlU2dUVlNWtvQTNkdTM5UT09External Link Disclaimer\nPasscode: ^8@HvK\n\nYou will have an opportunity to ask questions live during the virtual town hall and you may also submit questions in advance by emailing CDRHWebinars@fda.hhs.gov. \n\nPlease submit questions by Monday 12 p.m. ET before the Wednesday virtual town hall.\nIn the subject line of the email\, type Questions for the Virtual Town Hall Test Development and Validation During Public Health Emergencies.\n\n\nBackground:\nThe final transition guidances provide recommendations and clarity for medical device manufacturers that may or may not want to continue to distribute their devices after the relevant device EUA declaration related to COVID-19 under section 564 of the Federal Food\, Drug\, and Cosmetic Act terminates or the enforcement policies in certain COVID-19 device guidances are no longer in effect. \nThe FDA encourages stakeholders to review the two final guidances\, attend the CDRH webinar on April 18\, and reach out to the FDA if they have questions or concerns. In particular\, for manufacturers planning to seek marketing authorization for their devices\, the FDA recommends beginning work on a marketing submission\, including a transition implementation plan\, as described in the guidances. \n\nTransition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)\nTransition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
URL:https://globalbiodefense.com/event/test-development-and-validation-during-the-covid-19-public-health-emergency/
CATEGORIES:Government Hosted
LOCATION:https://fda.zoomgov.com/j/1612083563?pwd=NklWOE1jUlU2dUVlNWtvQTNkdTM5UT09#success
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230427T090000
DTEND;TZID=America/New_York:20230427T130000
DTSTAMP:20230421T193407Z
CREATED:20230421T163659Z
LAST-MODIFIED:20230421T193407Z
UID:56966-1682586000-1682600400@globalbiodefense.com
SUMMARY:Recombinant Protein-Based COVID-19 Vaccines Workshop
DESCRIPTION:The Biomedical Advanced Research and Development Authority (BARDA) and FDA will host a virtual workshop titled Recombinant Protein-Based COVID-19 Vaccines April 27\, 2023\, from 9:00 am EDT to 1:00 pm EDT. \nThe goals of the workshop are to provide a forum for product sponsors to discuss progress and technical challenges in the manufacturing when changing strain composition to currently circulating variants of SARS-CoV-2; and an open forum for collaborative discussions to facilitate advancement of recombinant protein-based COVID-19 vaccines. \nHighlighted topics include: \n\nPandemic preparedness\, target product profile\, timelines\, and the need for continued investment\nEpidemiology\, disease burden\, continued need for COVID-19 vaccines\nFeatures of novel vaccines\, need for next generation vaccines\nOvercoming challenges to address strain updates and pandemic readiness\nRecombinant COVID-19 vaccine presentations from Novavax\, Sanofi\, SK Bioscience\, Dyadic\, Biological E\, and Intravacc\n\nPlease visit the FDA’s Recombinant Protein-Based COVID-19 Vaccines Workshop site to register to attend online.
URL:https://globalbiodefense.com/event/fda-recombinant-protein-based-covid-19-vaccines-workshop/
CATEGORIES:Government Hosted
LOCATION:https://fda.zoomgov.com/meeting/register/vJIsd-GvrDgqGKQjMEzpDtzTCvGTY4xmZxk
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230427T120000
DTEND;TZID=America/New_York:20230427T163000
DTSTAMP:20230421T193340Z
CREATED:20230421T180232Z
LAST-MODIFIED:20230421T193340Z
UID:56980-1682596800-1682613000@globalbiodefense.com
SUMMARY:Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
DESCRIPTION:The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public listening meeting on 27 April 2023 to solicit input on methods and approaches (e.g.\, use of real-world evidence (RWE)\, registries) for capturing post approval safety and efficacy data for cell and gene therapy products. \nThe rapid pace of innovation for cell and gene therapy products holds promise for transforming medicine and creating treatment options for patients living with difficult\, rare\, and often incurable diseases. With an increasing number of cell and gene therapy products in development and the potential for more of these treatments to become available to patients in the future\, it is important to understand the full spectrum of long-term effects and collect accurate\, timely\, and comprehensive data to ensure these products remain safe\, effective\, and of high quality. The FDA is seeking input on methods\, approaches\, logistics\, privacy concerns\, and other aspects related to efficacy and safety data collection in the post-approval setting for cell and gene therapies. \nThis is a virtual public listening meeting and will be held via Zoom. The meeting is free and open to the public; however\, registration is required. Early registration is recommended. \nRegistration will close on Wednesday\, April 26\, 2023 at 11:59 p.m. ET. A recording and other relevant meeting materials will be posted online following the event. \nPlease visit the FDA CBER OTP Public Listening Meeting — Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products site to register.
URL:https://globalbiodefense.com/event/capturing-post-approval-safety-and-efficacy-data-on-cell-and-gene-therapy-products/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230504T080000
DTEND;TZID=America/New_York:20230504T120000
DTSTAMP:20230501T154445Z
CREATED:20230501T153634Z
LAST-MODIFIED:20230501T154445Z
UID:57174-1683187200-1683201600@globalbiodefense.com
SUMMARY:Prioritizing Actions for Epidemic and Pandemic Preparedness
DESCRIPTION:The Prioritizing Actions for Epidemic and Pandemic Preparedness Virtual Symposium will be held 4 May and 18 May 2023. \nThis first session will be held from 8:00am-12:00pm ET on 4 May 2023 and the second session from 8:00 am-12:00pm ET on 18 May 2023. \nThe purpose of this symposium is to convene global health planning stakeholders\, including those in government and academia\, and across health- and non-health sectors\, to strengthen the capacity for evidence-based prioritization of global health capabilities. Objectives of this meeting are the following: \n\nReview assessment tools and how\, independently and together\, they relate to national action planning.\nGain insight into how countries and organizations currently select priorities in funding for epidemic prevention\, detection\, and response.\nAssess evidence for effective prioritization approaches to building disease surveillance and risk communication capabilities.\nIdentify governance structures that can support robust and reliable systems for global health investments.\n\nAGENDA\nPolitical and Economic Context for Sustainable International Epidemic Preparedness: International Governance and Finance (Session 1)\nThe goal of this forward-looking discussion is to highlight critical needs\, challenges\, and gaps in international and national governance and financing for developing and maintaining critical capabilities needed to prevent\, detect\, and respond to future epidemics. \nModerator: Dr. Mercy Mwangangi\, AMREF Kenya \nSpeakers:\nRaj Panjabi\, White House National Security Council\nSara Hersey\, World Health Organization Health Emergencies\nPriya Basu\, Pandemic Fund Secretariat\, World Bank Group\nSaul Walker\, Coalition for Epidemic Preparedness Innovations (CEPI) \nPolitical and Economic Context for Sustainable International Epidemic Preparedness: Regional and Country Efforts and Building Trust (Session 2)\nThe goal of this forward-looking discussion is to highlight critical needs\, challenges\, and gaps in science\, public health\, and health security for strengthening and maintaining critical capabilities needed to prevent\, detect\, and respond to future epidemics. \nModerator: Dr. Mercy Mwangangi\, AMREF Kenya \nSpeakers:\nAyoade Alakija\, African Vaccine Delivery Alliance\, Pre-recorded Video\nIrma Makaliano\, University of the Philippines\nDuncan Selbie\, International Association of National Public Health Institutes\nJailson Correia\, Instituto de Medicina Integral Professor Fernando Figueira\nWessam Mankoula\, Africa Centers for Disease Control \nAction Groups Preview \n\nSituational Awareness in the Context of Health and Diseases: Larry Brilliant\, Pandefense Advisory\nBuilding Trust\, Transparency\, and Risk Communication Capabilities: Richard Garfield\, US Centers for Disease Control and Prevention\nStrengthening Global Health Security through Strong Country-Level Infrastructure for Effective Governance\, Financing\, and Accountability: Julie Wahl\, Resolve to Save Lives\nGlobal Health Capacity and Functionality Assessment: Jessica Petrillo\, US Agency for International Development\nCountries’ and Organizations’ Experiences in Preparedness and Response Planning: Erwin Calgua\, Universidad de San Carlos de Guatemala\n\nPlease visit the National Academies’ Prioritizing Actions for Epidemic and Pandemic Preparedness Virtual Symposium page for more information and to register for virtual attendance.
URL:https://globalbiodefense.com/event/prioritizing-actions-for-epidemic-and-pandemic-preparedness/
CATEGORIES:Webinar-Webcast,Workshop
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230507
DTEND;VALUE=DATE:20230511
DTSTAMP:20230422T170026Z
CREATED:20230421T232418Z
LAST-MODIFIED:20230422T170026Z
UID:57016-1683417600-1683763199@globalbiodefense.com
SUMMARY:ABRF 2023 Annual Meeting | Association of Biomolecular Resource Facilities
DESCRIPTION:The Annual Meeting of the Association of Biomolecular Resource Facilities (ABRF 2023) will be held 7-10 May 2023 in Boston\, Massachusetts. \nHighlighted topics and presentations include: \n\nBusiness Skills for Core Facility Directors\, Managers and Administrators\nAdvancing Single Cell in Core Laboratories\nImplementing Spatial Transcriptomics in Core Facilities\nUsing R/R-Studio for reproducible data analysis and visualization\nSpatial Biology for Shared Research Laboratories\nGenome Editing Cores and Best Practices\nSample Preparation for Single Cell Genomics\nNon-Biological Core Facilities and Their Place within ABRF\nDigital PCR–applications\, challenges\, and use in a core setting\nNew Sequencers and Evolving Next Generation Sequencing Landscape\nWhat Do We Hand Over When an Analysis Is Finished? A spectrum-style discussion\nCell Sorting Technology Acquisition in the SRL: Evaluation\, Integration and Deployment to Users\nUpdates from the Microbiome and Metagenomics\, Genome Engineering\, and Genomics Research Groups\n\nPlease visit the ABRF 2023 Annual Meeting site for more information and to register.
URL:https://globalbiodefense.com/event/abrf-2023-annual-meeting-association-of-biomolecular-resource-facilities/
LOCATION:Sheraton Boston Hotel\, 39 Dalton Street\, Boston\, MA\, 02199\, United States
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230511T154500
DTEND;TZID=America/New_York:20230511T170000
DTSTAMP:20230421T195422Z
CREATED:20230421T195422Z
LAST-MODIFIED:20230421T195422Z
UID:56995-1683819900-1683824400@globalbiodefense.com
SUMMARY:Collaborating on Culture in the New Era of Smarter Food Safety
DESCRIPTION:Live from the Food Safety Summit: Measure What You Treasure\nMay 11\, 2023\, from 3:45 pm 5:00 pm ET \nThe upcoming webinar will focus on the importance of assessing food safety culture in an organization. \nGuest speakers include: \n\nDonald A. Prater\, DVM\, Acting Director\, Office of Food Policy and Response\, FDA\nConrad Choiniere\, PhD\, Director\, Office of Analytics and Outreach\, Center for Food Safety and Applied Nutrition\, FDA\nLone Jespersen\, Principal and Founder\, Cultivate SA\nVanessa Coffman\, Director\, Alliance to Stop Foodborne Illness\nBrian Perry\, Executive Food Safety & Quality Leader\, TreeHouse Foods\, Inc\nKarleigh Bacon\, Director of U.S. Supply Chain Food Safety\, Science & Regulatory\, McDonald’s Corporation\nPhilip Bronstein\, Ph.D.\, Assistant Administrator\, Office of Field Operations\, Food Safety and Inspection Service\, Food Safety and Inspection Service\, USDA\n\nThe U.S. Food and Drug Administration and Stop Foodborne Illness\, a non-profit public health organization\, are collaborating on a webinar series that explores food safety culture\, one of the core elements in FDA’s New Era of Smarter Food Safety initiative. \nThe New Era of Smarter Food Safety blueprint states that dramatic improvements in reducing the burden of foodborne illness cannot be made without doing more to influence the beliefs\, attitudes\, and\, most importantly\, the behaviors of people and the actions of organizations. \nPlease visit the FDA’s Collaborating on Culture in the New Era of Smarter Food Safety event page for more information and to register to attend this virtual event.
URL:https://globalbiodefense.com/event/collaborating-on-culture-in-the-new-era-of-smarter-food-safety/
CATEGORIES:Government Hosted
LOCATION:https://zoom.us/webinar/register/WN_uMaG_U92TLGqb-2bTozXSw#/registration
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DTSTART;TZID=America/New_York:20230518T080000
DTEND;TZID=America/New_York:20230518T120000
DTSTAMP:20230501T154139Z
CREATED:20230501T153817Z
LAST-MODIFIED:20230501T154139Z
UID:57177-1684396800-1684411200@globalbiodefense.com
SUMMARY:Prioritizing Actions for Epidemic and Pandemic Preparedness
DESCRIPTION:The Prioritizing Actions for Epidemic and Pandemic Preparedness Virtual Symposium will be held 18 May 2023. \nThis is the second of two sessions. The purpose of this symposium is to convene global health planning stakeholders\, including those in government and academia\, and across health- and non-health sectors\, to strengthen the capacity for evidence-based prioritization of global health capabilities. \nObjectives of this meeting are the following: \n\nReview assessment tools and how\, independently and together\, they relate to national action planning.\nGain insight into how countries and organizations currently select priorities in funding for epidemic prevention\, detection\, and response.\nAssess evidence for effective prioritization approaches to building disease surveillance and risk communication capabilities.\nIdentify governance structures that can support robust and reliable systems for global health investments.\n\nAGENDA\nHealth Security Action Areas: Issues and Opportunities\nThe goals of these discussions are to review success and failures\, use of assessment tools\, identify outstanding gaps and determine critical areas for action to sustainably improve capabilities in three areas. \nSituational Awareness in the Context of Health and DiseasesThe goal of this discussion is to re-set expectations at a higher-level of what can be done to keep both public health and the general public aware of changes in disease risks as early as possible by combining many current surveillance systems with new sources of disease data to form near real time awareness of constantly changing disease risks. \nTopics covered in this discussion include: \n\nCurrent tools for disease surveillance and the international tools used to evaluate the effectiveness of these systems\nRoutine methods and genetic surveillance for assessing situational awareness\nRecent innovations in detection in detection of novel diseases and use of closer-to-real-time monitoring of critical changes in endemic disease\nRecent experience including new types of disease surveillance and combinations of traditional and new methods to improve situational awareness\nIntegration of surveillance tools to realize near-real-time situational awareness\n\nModerator: Larry Brilliant\, Pandefense Advisory \nDiscussants:Mark Smolinski\, Ending PandemicsPatipat Keng Susumpow\, Opendream CoChanne Suy\, Co–Founder\, Kawsang \nBuilding Trust\, Transparency\, and Risk Communication Capabilities\nThe goal of this discussion is to review existing guidance and frameworks for risk communication\, highlighting approaches that are particularly effective for communicating risk about epidemics and describing approaches that have been demonstrated to be less effective or ineffective in communicating risks. \nModerator: Richard Garfield\, U.S. Centers for Disease Control and Prevention \nDiscussants:\nKatelyn Jetelina\, Your Local Epidemiologist\nRania Elessawi\, UNICEF\nBaruch Fischhoff\, Carnegie Mellon University \nStrengthening Global Health Security through Strong Country-Level Infrastructure for Effective Governance\, Financing\, and Accountability\nA country’s performance during an infectious disease outbreak is only as strong as its ability to leverage multisectoral partnerships; coordinate at national\, subnational and community levels; and continuously develop and strengthen health and public health system capacity to prevent and respond to outbreaks. \nThe goal of this discussion is to examine how improving global health security begins at the country-level and how countries can strengthen their public health architecture for epidemic preparedness and response through effective mechanisms for governance\, financing\, and accountability. This group will focus on the following questions: \n\nHow might countries /organizations ensure effective multisectoral governance at country-level?\nHow might countries /organizations foster accountability among partners and stakeholders that drives continuous quality improvement and well-prioritized investments?\n\nModerators\nJulie Wahl\, Resolve to Save Lives\nGisela Scaglia\, Former Member of Parliament Argentina \nDiscussants\nAminu Magashi Garba\, Africa Budget Network\nImmaculate Nabukenya\, Makerere University\nAbrham Ejigu – Senior Project Manager\, Resolve to Save Lives\, Ethiopia \nCross-Cutting Action Areas: Issues and Opportunities\nThe goals of these discussions are to review success and failures\, use of assessment tools\, identify outstanding gaps and determine critical areas for action to sustainably improve capabilities in three overarching areas \nGlobal Health Security Capacity and Functionality Assessment\nTimely access to quality\, actionable data underpins effective prioritization of investments to address GHS capacity and functionality gaps. The goal of this session is to discuss and identify critical needs\, challenges\, gaps\, and\nopportunities to improve GHS capacity and functionality assessment tools\, their use\, and the use of the data they generate to inform decision making on strengthening and maintaining critical capabilities needed to prevent\, detect\, and respond to any future epidemics. Participants will discuss the following issues: \n\nIdentify challenges in the use of existing tools (including accessibility) and opportunities to improve them.\nIdentify opportunities to improve interoperability\, interconnectedness\, and integration of assessment tools and data.\nIdentify opportunities to improve linkages between capacity/capability guidance and assessment tools.\nParticipants will have a worksheet to contribute to prior to and following the discussion.\nParticipants will use Jamboard to add suggested actions for addressing identified gaps.\n\nModerators\nAamer Ikram\, National Institutes of Health Pakistan\nJessica Petrillo\, U.S. Agency for International Development \nDiscussants:\nAnne Liu\, Gates Ventures\nDr. Magda Robalo Correia e Silva\, Institute for Global Health and Development\nCharles Bebay\, ECTAD Regional Manager for Eastern and Southern Africa\,\nFood and Agriculture Organization \nCountries’ and Organizations’ Experiences in Preparedness and Response Planning\nThe goal of this discussion is to identify lessons and best practices for preparedness and response at the national level\, and identify actions on policy and practice for improving preparedness and planning for the next pandemic by learning from what went well and what went less well in national contexts. \nExamples exist of countries on good planning practices to address the SARS-CoV-2 pandemic. These countries have observed strong and weak points in the national system through systematic monitoring and evaluation (M&E) tools (e.g.\, IHR\, Joint External Evaluation\, Universal Health and Preparedness Review). Before engaging in discussion about these topics\, participants will hear from two examples of countries from different perspectives. This discussion will focus on the following questions: \n\nWhat are the actual practices in a term of multisectoral approach that the country is adopting as a result of learning in this symposium from the M&E tool?\nWhat’s the nature of the reinforcement process of preparedness and response planning at the national level?\n\nParticipants will be asked to suggest approaches and actions to guide each country’s decision to implement and strengthen the use of their preparation and response plans with academia\, donors\, and private partners. \nModerators\nSoawapak Hinjoy\, Department of Disease Control\, Ministry of Health\, Thailand\nErwin Humberto Calgua Guerra\, Universidad de San Carlos de Guatemala\nArminder Kaur Deol\, Coalition of Epidemic Preparedness Innovations \nDiscussants:\nJeffery Cutter\, Ministry of Health Singapore\nAli Ardalan\, Health Systems in Emergencies Lab\, World Health Organization\nRegional Officer for the Eastern Mediterranean \nPlease visit the National Academies’ Prioritizing Actions for Epidemic and Pandemic Preparedness Virtual Symposium page for more information and to register for virtual attendance.
URL:https://globalbiodefense.com/event/prioritizing-actions-for-epidemic-and-pandemic-preparedness-2/
CATEGORIES:Webinar-Webcast,Workshop
LOCATION:
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DTSTART;TZID=America/New_York:20230518T083000
DTEND;TZID=America/New_York:20230518T173000
DTSTAMP:20230421T194600Z
CREATED:20230421T194600Z
LAST-MODIFIED:20230421T194600Z
UID:56993-1684398600-1684431000@globalbiodefense.com
SUMMARY:VRBPAC Meeting on Pfizer's ABRYSVO Respiratory Syncytial Virus Vaccine
DESCRIPTION:Vaccines and Related Biological Products Advisory Committee May 18\, 2023 Meeting Announcement \nOn 18 May 2023\, the committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine)\, manufactured by Pfizer Inc.\, with a requested indication\, in Biologics License Application (BLA) 125768 (STN 125768/0)\, for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals. \nAdvisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA\, which generally follows the recommendations but is not legally bound to do so. Please see\, “Advisory Committees Give FDA Critical Advice and the Public a Voice\,” for more information. \nMeeting Materials\nFDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting\, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Additional materials will be posted on FDA’s website after the meeting. \nMaterials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page. \nThe meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. \nPublic Participation Information\nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. \nThe Docket Number is FDA-2023-N-1338 \nComments received on or before May 11\, 2023\, will be provided to the committee. Comments received after May 11\, 2023\, and by May 17\, 2023\, will be taken into consideration by FDA. In the event the meeting is canceled\, FDA will continue to evaluate any relevant applications or information\, and consider any comments submitted to the docket\, as appropriate. \nPlease visit the VRBPAC Meeting Announcement page for more information.
URL:https://globalbiodefense.com/event/vrbpac-meeting-on-pfizers-abrysvo-respiratory-syncytial-virus-vaccine/
CATEGORIES:Government Hosted
LOCATION:https://www.youtube.com/watch?v=NXVMILYvocM
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DTSTART;TZID=America/New_York:20230524T090000
DTEND;TZID=America/New_York:20230524T140000
DTSTAMP:20230421T193224Z
CREATED:20230421T193224Z
LAST-MODIFIED:20230421T193224Z
UID:56991-1684918800-1684936800@globalbiodefense.com
SUMMARY:Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
DESCRIPTION:FDA CDER Office of Pharmaceutical Quality is offering a five-hour webinar to discuss reporting requirements and expectations for Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR). The statutory reporting requirements are found in 21 CFR 314.81 (for FAR) and 21 CFR 600.14 (for BPDR). FDA will share how it assesses these reports and how they support risk-based decisions in a variety of contexts. These reports provide an early warning signal to the agency that a marketed product may harm patients due to a deviation or incident that has occurred. \nThis webinar will present FDA expectations for conducting root cause analysis and then implementing and assessing effectiveness of corrective action and preventive action plans (CAPAs) to mitigate the severity and probability of harm. Attendees will learn how the agency is integrating advanced analytics (e.g.\, machine learning and natural language processing) to innovate processes and facilitate proactive approaches to quality risk management. FDA will also share some common reporting errors as well as best practices for report submission. \nTOPICS COVERED\n\nPost-market reporting (FARs and BPDRs) requirements and expectations – who is responsible for reporting\, how do you report\, and what happens if they are not reported\nFDA’s use of post-market quality defect reports to support risk-based decisions\nThe parameters of OPQ’s assessment for FARs and BPDRs (i.e.\, how are they assessed and what is the overall business process OPQ manages\nThe integration of advanced analytics into OPQ’s post-market quality defect report program\n\nLEARNING OBJECTIVES\n\nWhat are the post-market reporting requirements and expectations for application holders and manufacturers.\nHow does FDA manage and assess the reports.\nWhat to expect regarding follow-ups and engagement from FDA after submitting a report.\nHow does FDA utilize FARs/BPDRs to support regulatory decisions (e.g.\, surveillance inspection prioritization\, pre-approval/pre-license inspections\, regulatory flexibility\, etc.).\nHow does FDA integrate FARs/BPDRs into their overall assessment on the state of pharmaceutical quality.\nHow is FDA innovating processes for managing FARs/BPDRs with the integration of advanced analytics.\n\nINTENDED AUDIENCE\n\nNDA\, ANDA\, BLA applicant holders\nGeneric and New Drug Pharmaceutical manufacturers (including CDMOs)\nContract Testing Laboratories\nRegulatory Affairs professionals supporting post-marketing reporting requirements\nQuality Assurance and Quality Control professionals\nConsultants supporting pharmaceutical manufacturers\nForeign Regulators\n\nFDA RESOURCES\n\n21 CFR 314.81\n21 CFR 600.14\nField Alert Reports\nCDER – Biological Product Deviations\n\nCONTINUING EDUCATION\nReal-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event. \nThis webinar has been: \n\npre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.\npre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations\, operations or management\, or to the candidate’s clinical research therapeutic area.\npre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration\napproved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.\n\nPlease visit the FDA’s Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR) meeting page for more information and to register to attend virtually.
URL:https://globalbiodefense.com/event/update-on-field-alert-reports-far-and-biological-product-deviation-reports-bpdr/
CATEGORIES:Government Hosted
LOCATION:
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