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X-WR-CALDESC:Events for Global Biodefense
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DTSTART:20210314T070000
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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:
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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:
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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
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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:
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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:
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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:
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