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DTSTART;VALUE=DATE:20230724
DTEND;VALUE=DATE:20230729
DTSTAMP:20230421T161848Z
CREATED:20230421T161759Z
LAST-MODIFIED:20230421T161848Z
UID:56962-1690156800-1690588799@globalbiodefense.com
SUMMARY:Just Breathe: ARDS Therapeutics Pitch Event
DESCRIPTION:A BARDA-Sponsored Phase 2 ARDS Platform Clinical Trial \nBARDA will host ‘Just Breathe – An ARDS Therapeutics Pitch Event’ on July 24-28\, 2023 to support development of threat-agnostic and host-directed therapeutic candidates to address acute respiratory distress syndrome (ARDS). The event will be held in a virtual format. \nThe Biomedical Advanced Research and Development Authority Influenza & Emerging Infectious Diseases Division plans to support a randomized\, double-blinded\, placebo-controlled\, multi-center U.S. Phase 2 platform clinical trial that investigates multiple immune modulators or other host-directed therapeutics in hospitalized adult patients with acute respiratory distress syndrome (ARDS). In this trial\, BARDA will evaluate the safety and efficacy of novel threat-agnostic and host-directed therapeutics that could address ARDS caused by known or unknown health security threats such as pandemic influenza\, COVID-19\, other emerging infectious diseases\, and chemical\, biological\, radiological\, and nuclear (CBRN) incidents. \nMore information about the design of the phase 2 ARDS platform clinical trial is available in the draft protocol synopsis under the BAA Area of Interest (AOI) 9.7 (closed March 14\, 2023). \nTo participate in the Just Breathe Pitch Event\, drug sponsors will need to submit the following: \n\nSlide deck containing the required information about the proposed therapeutic candidate\nA current Investigator’s Brochure (IB) for the proposed therapeutic candidate\nSubmission cover page form\n\nInterested drug sponsors will have the opportunity to submit questions and receive feedback from BARDA on their initial slide deck submissions for revision and submit the updated slide deck for for the event. \nThe final (revised) slide deck submission and the IB will be evaluated by a scientific review process based on pre-specified criteria outlined in the presentation template. Drug sponsors with most competitive submissions will be invited to present virtually about their products and attend a live Q&A in front of an interagency review panel. \nUp to three phase 2-ready therapeutic candidates representing different mechanisms of action will be selected for inclusion in the planned BARDA-sponsored phase 2 ARDS platform clinical trial. \nPlease visit BARDA’s Influenza & Emerging Infectious Diseases Division website for additional program information and visit the Just Breathe – An ARDS Therapeutics Pitch Event page for submission instructions\, provided templates\, evaluation criteria\, and a detailed timeline. All pre-submission inquiries and submissions should be submitted to IEIDD_Tx@hhs.gov. Critical due dates for this pitch event are listed below: \n\nFinal day to submit questions: May 26\, 2023\, by 5 p.m. EDT\nInitial slide deck submission: June 2\, 2023\, by 5 p.m. EDT\nFinal (revised) slide deck submission: June 30\, 2023\, by 5 p.m. EDT\nPitch event presentation invitations to drug sponsors with the most competitive therapeutic candidates: July 10\, 2023\nJust Breathe – An ARDS Therapeutics Pitch Event: July 24-28\, 2023\n\nSource: Biomedical Advanced Research and Development Authority
URL:https://globalbiodefense.com/event/just-breathe-ards-therapeutics-pitch-event/
CATEGORIES:Government Hosted,Industry Day,Innovation Challenge
ATTACH;FMTTYPE=image/png:https://globalbiodefense.com/wp-content/uploads/2023/04/barda-just-breathe-ards-clinical-trial-therapeutics.png
LOCATION:
END:VEVENT
BEGIN:VEVENT
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:
END:VEVENT
BEGIN:VEVENT
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
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
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: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: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: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;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: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: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;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;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;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: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;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: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;TZID=America/New_York:20221013T120000
DTEND;TZID=America/New_York:20221013T130000
DTSTAMP:20220921T205205Z
CREATED:20220921T205205Z
LAST-MODIFIED:20220921T205205Z
UID:56440-1665662400-1665666000@globalbiodefense.com
SUMMARY:Quality Considerations for MAM for Therapeutic Proteins
DESCRIPTION:The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS) based peptide mapping approach used for the identification and quantitation of product quality attributes (PQAs) in therapeutic proteins. \nThe U.S. FDA Center for Drug Evaluation and Research (CDER)\, Emerging Technology Program (ETP) has assessed the use of MAM in quality control environments and laboratory resources have been developed to improve the FDA’s understanding of the approach. \nThis meeting will discuss: \n\nHow the LC-MS based multi-attribute method can be used for quality control of therapeutic proteins\nHow the multi-attribute method can detect multiple product quality attributes or critical quality attributes within a single LC-MS run\nKey considerations for implementation of the multi-attribute method\, including risk assessment\, method validation\, new peak detection\, and conventional method comparisons\n\nFor advance registration\, please visit the MAM for Therapeutic Proteins meeting page
URL:https://globalbiodefense.com/event/quality-considerations-for-mam-for-therapeutic-proteins/
CATEGORIES:Government Hosted
LOCATION:https://fda.zoomgov.com/webinar/register/WN_LKO4FXAlSfSuP89383sikg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221011
DTEND;VALUE=DATE:20221012
DTSTAMP:20220921T200930Z
CREATED:20220921T200613Z
LAST-MODIFIED:20220921T200930Z
UID:56431-1665446400-1665532799@globalbiodefense.com
SUMMARY:FDA NanoDay Symposium 2022
DESCRIPTION:The FDA NanoDay Symposium 2022 will be held on 11 October 2022. The event will address drug development of products that contain nanomaterials in their formulation and how the newly finalized guidance to industry for products that contain nanomaterials can be implemented in filings to the FDA. \nHighlighted topic areas include: \n\nPrimary Chemistry Manufacturing and Controls (CMC) and nonclinical hurdles for developing products that contain nanomaterials\nDevelopment and Characterization of Generic Drug Products Containing Nanomaterials\nConsiderations for the Quality\, Safety and Efficacy of Prophylactic Lipid Nanoparticle mRNA Vaccines\nCase studies on the development of the COVID mRNA lipid nanoparticle vaccine products\nFuture of Continuous Manufacturing of Drug Products Containing Nanomaterials\nEfforts to establish standards and standard methods for monitoring products that contain nanomaterials\nA contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products\nA nonclinical perspective of developmental challenges of products that contain nanomaterials\nSafety Evaluation of Food Contact Substances Containing Nanomaterials\n\nThe intended audience includes: Regulatory science and regulatory affairs professionals working on drug products\, including biologicals\, that contain nanomaterials and submit IND/NDA/BLA/ANDA applications for FDA review; researchers working on applications of nanotechnology for pharmaceutical products\, analytical methodology for control of pharmaceuticals that contain nanomaterials\, and nonclinical studies to support human clinical trials; and foreign regulators who review comparable pharmaceutical products that contain nanomaterials. \nPlease visit the FDA’s NanoDay Symposium 2022 website for more information. \nFDA RESOURCES\n\nGUIDANCE DOCUMENT: Drug Products\, Including Biological Products\, that Contain Nanomaterials – Guidance for Industry; APRIL 2022\nGUIDANCE DOCUMENT: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology – Guidance for Industry; JUNE 2014\nGUIDANCE DOCUMENT: Liposome Drug Products: Chemistry\, Manufacturing\, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; APRIL 2018\nGUIDANCE DOCUMENT: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs\, Including Well-Characterized\, Therapeutic\, Biotechnology-derived Products – Guidance for Industry; NOVEMBER 1995
URL:https://globalbiodefense.com/event/fda-nanoday-symposium-2022/
CATEGORIES:Continuing Education,Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221006T083000
DTEND;TZID=America/New_York:20221006T130000
DTSTAMP:20220921T202014Z
CREATED:20220921T201913Z
LAST-MODIFIED:20220921T202014Z
UID:56435-1665045000-1665061200@globalbiodefense.com
SUMMARY:VRBPAC Meeting - Vaccine Strain Selection 2023 Southern Hemisphere Flu Season
DESCRIPTION:The FDA Vaccines and Related Biological Products Advisory Committee will convene on 6 October 2022 in open session to discuss the Strain Selection for the Influenza Virus Vaccines for the 2023 Southern Hemisphere Influenza Season. \nMaterials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page. Interested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. The Docket Number is FDA-2022-N-1745 \nPlease visit the FDA VRBPAC Meeting website for more information.
URL:https://globalbiodefense.com/event/vrbpac-meeting-vaccine-strain-selection-2023-southern-hemisphere-flu-season/
CATEGORIES:Government Hosted
LOCATION:https://youtu.be/qazitJMHZK4
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221005
DTEND;VALUE=DATE:20221006
DTSTAMP:20220922T145702Z
CREATED:20220922T145702Z
LAST-MODIFIED:20220922T145702Z
UID:56457-1664928000-1665014399@globalbiodefense.com
SUMMARY:Study Data Standards Update for FDA CBER
DESCRIPTION:FDA’s Center for Biologics Evaluation and Research (CBER)  will host a free virtual format workshop on 5 October 2022 entitled Study Data Standards Update for CBER: Your Guide to a Successful Submission. \nCBER will discuss CBER’s support and requirement starting March 15\, 2023 for the Standard for the Exchange of Nonclinical Data (SEND) \, which was published in the Federal Register on July 14\, 2020\, and the addition of SEND for CBER to the FDA Data Standards Catalog. \nFDA will discuss the brief background of the new requirement and how SEND will aid CBER reviewers. The webinar will also address common issues in submission data. \nINTENDED AUDIENCE\n\nRegulatory science and regulatory affairs professionals working on clinical and non-clinical data submissions for BLAs/NDAs/ANDAs/INDs to CBER\nConsultants focused on clinical and non-clinical data submission\nHealthcare professionals specializing in clinical and non-clinical data\nForeign regulators\n\nFDA RESOURCES\n\nFederal Register Notice regarding SEND for CBER\nFDA Data Standards Catalog\nStudy Data Technical Conformance Guide\nFDA Study Data Standards Resources\nEmail: cber-edata@fda.hhs.gov\n\nPlease visit FDA’s Study Data Standards Update for CBER: Your Guide to a Successful Submission meeting webpage for more information.
URL:https://globalbiodefense.com/event/study-data-standards-update-for-fda-cber/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220929T110000
DTEND;TZID=America/New_York:20220929T150000
DTSTAMP:20220924T161732Z
CREATED:20220924T161603Z
LAST-MODIFIED:20220924T161732Z
UID:56507-1664449200-1664463600@globalbiodefense.com
SUMMARY:National Biodefense Science Board Public Meeting
DESCRIPTION:The next public meeting of the National Biodefense Science Board (NBSB) will take place on Thursday\, September 29. \nJoin NBSB members\, distinguished guests\, federal leaders\, and subject matter experts exploring topics such as how best to support rural and underserved communities during the COVID-19 pandemic\, use of virtual healthcare during disasters\, and health system operational data considerations during a health emergency. For additional details and meeting agenda topics\, please see the NBSB Public Meeting page. An agenda for the meeting is posted on the website. \nHighlighted agenda items include: \n\nReadiness and Resilience Working Group Readout\nCountermeasures and Operational Research Working Group Readout\nDisaster and Public Health Emergency Training Needs\, Challenges\, and Opportunities for the Health Workforce in the United States\nOpen Discussion – Additional Key Biodefense Lessons from COVID-19\n\nAdvanced registration is required. To register for the meeting and for additional information\, visit the NBSB Public Meeting page. \nRegister to Address the NBSB\nThe NBSB are inviting people with expertise or experience related to the collection\, analysis\, and operational use of health data to improve access to and resilience of virtual health care to address the Board and/or experience and expertise addressing rural and underserved communities during the COVID-19 pandemic. \nWe are particularly interested in hearing stakeholder input related to the following topics: \nOperational Health Data for Disaster Response\n\nWhat are your concerns about the confidentiality of your health data or how it might be used?\nWhat are your concerns with the current HHS data reporting requirements for health systems\, including the format\, timing\, and extent of data that must be submitted?\nShould data reporting requirements\, or modified requirements\, be continued after the COVID-19 reporting stops?\nWhat are the current training needs for healthcare staff to meet the requirements for collection and reporting of health data?\nWhat is the level of effort (i.e. staffing and person-time) required to satisfy all of the current health system reporting requirements?\nIf your health care or public health organization has agreements in place to share information among regional partners\, do you have processes in place to improve data sharing during a disaster? Has data sharing during disasters led to an improved disaster response?\nIf your health care or public health organization has agreements in place to share information among regional partners\, do you have any special measures in place to ensure that rural and underserved communities are represented?\n\nVirtual Healthcare for Disaster Response\n\nWhat could be done to improve the reliability and availability of internet access and the appropriate computers or software? If available\, is the use of telephone or radio an acceptable option for medical care during a disaster?\nWhat are your concerns about the continuity of care\, including the availability of your own medical history and proper recording of virtual care?\nAre there adequate resources in place to ensure that you receive the medications you need during a disaster?\nWould you be willing to have a “family visit” for healthcare\, where multiple people are treated on the same virtual visit?\n\nUpdate: NBSB currently has as many public speakers as can accommodated in the time available\, so please send written comments on related topics to NBSB@hhs.gov\, which will be shared with the board members ahead of the meeting. Additional meeting materials will be made available to the public on the NBSB Public Meeting page.
URL:https://globalbiodefense.com/event/national-biodefense-science-board-public-meeting-4/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220928
DTEND;VALUE=DATE:20220930
DTSTAMP:20240623T193106Z
CREATED:20220921T190315Z
LAST-MODIFIED:20240623T193106Z
UID:56428-1664323200-1664495999@globalbiodefense.com
SUMMARY:GBHI 2022 - 5th Annual Global Bioequivalence Harmonization Initiative Meeting
DESCRIPTION:The goal of the Global Bioequivalence Harmonization Initiative (GBHI) conference is to offer the most informative and up to date science and regulation of bioequivalence in global drug development.  \nThe FDA AAPS EUFEPS 5th Annual GBHI Meeting will be held 28-29 September 2022. GBHI workshop provides an open forum for pharmaceutical scientists from academia\, industry and regulatory agencies to discuss various bioequivalence topics at issue including: \n\nFed vs fasted studies for immediate release dosage forms\nRelevance of excipients\, disintegration/dissolution specificities\, drug substance properties and physiological GI conditions\nReplicate design for BE of Highly Variable Drugs\ntwo-stage design and Pharmacokinetic modelling as supportive tools for BE assessment\nScientifically-based approaches for a waiver of clinical endpoint trials\nStudy design and acceptance criteria\n\nThis conference is intended for leaders in Academia\, the Pharmaceutical and Biotechnology Industry (PhRMA\, BIO\, GPhA)\, contract research organizations\, API manufacturers\, and domestic and international regulatory agencies in positions to affect the science and regulation of drug discovery and development\, who wish to stay abreast of the national and international initiatives affecting the development of safe and effective pharmaceutical drug products. \nPlease visit the FDA’s Global Bioequivalence Harmonization Initiative (GBHI) conference website for more information.
URL:https://globalbiodefense.com/event/gbhi-2022-5th-annual-global-bioequivalence-harmonization-initiative-meeting/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220926T103000
DTEND;TZID=America/New_York:20220926T173000
DTSTAMP:20220907T151745Z
CREATED:20220907T151724Z
LAST-MODIFIED:20220907T151745Z
UID:56350-1664188200-1664213400@globalbiodefense.com
SUMMARY:IARPA PICARD Program Proposers' Day
DESCRIPTION:The IARPA Pursuing Intelligent Complex Aerosols for Rapid Detection (PICARD) program will host a Proposer’s Day on 26 September 2022 to introduce the PICARD program to potential proposers and to provide information on technical requirements and program objectives. The PICARD program intends to develop a fieldable sensing platform for the rapid identification of aerosol particles in plumes. This platform will address both point detection (in situ) and standoff detection capabilities that focus on the complexity of aerosols with non-uniform sizes\, structures\, and chemical composition as well as dispersion in challenging environments. \nThe goal of PICARD is to develop novel integrated hardware and software tools that will improve the current state of the art with respect to chemical specificity\, accuracy\, and sensitivity. \nThe PICARD Proposers’ Day is a hybrid event that will be broadcast via the Webex video conference platform for remote attendees. In person participation is encouraged to facilitate information exchange and team forming. For planning purposes\, the venue is located near the Ballston Metro Station in Arlington\, VA. A recorded video of the meeting will be made available to the public on the IARPA website after the event. \nProposers’ Day Registration Closes: Friday\, September 16\, 2022 at noon EDT. Please visit IARPA’s PICARD Proposers’ Day website for more information. \n 
URL:https://globalbiodefense.com/event/iarpa-picard-program-proposers-day/
LOCATION:Ballston Metro Station\, Arlington\, VA\, United States
CATEGORIES:Government Hosted
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/09/iarpa-picard-intelligent-complex-aerosol-rapid-detection.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220926
DTEND;VALUE=DATE:20220928
DTSTAMP:20220921T174333Z
CREATED:20220921T174333Z
LAST-MODIFIED:20220921T174333Z
UID:56420-1664150400-1664323199@globalbiodefense.com
SUMMARY:MAQC 2022 - Massive Analysis and Quality Control Society Conference
DESCRIPTION:The 5th Annual Meeting of the FDA/National Center for Toxicological Research (NCTR) – Massive Analysis and Quality Control Society (MAQC) 2022 Conference will be held September 26-27\, 2022\, at the U.S. FDA Headquarters\, White Oak Campus in Silver Spring MD. \nConference presentations\, abstracts\, and discussions will include themes around: Explainable/Reproducible AI/ML\, AI/ML in health-related datasets\, SARS-CoV-2 and public health\, Single-cell\, genomics\, image analysis\, reference samples\, reproducible science and more. \nHighlighted topics and presentations include: \n\nDARPA’s explainable AI (XAI) program: A retrospective\nDrug repurposing for COVID-19 using explainable machine learning and mechanistic models of signal transduction circuits related to SARS-CoV-2 infection with real world data validation\nAn automated bioinformatic software testing and benchmarking platform to standardize the development of accurate\, reproducible\, and scalable omics analysis tools\nLeaSH: a High-Throughput COVID-19 Test to Profile Viral and Host Transcriptomes by Next Generation\nSequencing\nSome non-obvious factors that enhance or diminish observed and theoretical Illumina library complexity\nAI or Animal – A reproducibility perspective\nReproducible AI for supporting regulatory applications – a case study\nImproving preclinical pathology analysis with PathologAI\nExplainable approach for species identification using LIME\nEvaluation of mutagenic susceptibility of different stages in germ cell development of Caenorhabditis elegans using next generation sequencing\nIntegrated Calling and Evaluation of Gene Fusion Detection by Targeted RNA Sequencing of Reference Samples with Long and Short Reads\nMutual genome and transcriptome enrichment and sequencing in single cells with ResolveOME amplification chemistry to illuminate complex biological mechanisms\n\nPlease visit the Massive Analysis and Quality Control Society (MAQC) 2022 Conference website for more information and to register.
URL:https://globalbiodefense.com/event/maqc-2022-massive-analysis-and-quality-control-society-conference/
LOCATION:FDA White Oak Campus\, 10903 New Hampshire Ave\, Silver Spring\, MD\, 20993\, United States
CATEGORIES:Government Hosted,Webinar-Webcast
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220922T143000
DTEND;TZID=America/New_York:20220922T153000
DTSTAMP:20220921T203623Z
CREATED:20220921T203623Z
LAST-MODIFIED:20220921T203623Z
UID:56437-1663857000-1663860600@globalbiodefense.com
SUMMARY:Navigating Avian Influenza: From Prevention to Recovery
DESCRIPTION:Hear insights and information from APHIS and other experts on steps to take and what to expect during a bird flu outbreak during a free webinar on 22 September 2022. \nLearn from USDA and other experts about how to keep your flocks safe from highly pathogenic avian influenza (HPAI). This session is for enthusiasts\, farmers\, educators\, and anyone interested in signs and symptoms of HPAI\, what to watch out for during fall migration\, and how to develop an effective biosecurity and response plan. Hear about one educational farm’s experience managing a potential HPAI outbreak and get tips on how to keep your poultry flocks safe. \nPlease register for the Navigating Avian Influenza webinar in advance.
URL:https://globalbiodefense.com/event/navigating-avian-influenza-from-prevention-to-recovery/
CATEGORIES:Government Hosted
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/09/navigating-avian-influenza-usda.jpg
LOCATION:https://us02web.zoom.us/webinar/register/WN_z8GAVnu2SkiAfdqfMXgK0g
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220922T083000
DTEND;TZID=America/New_York:20220922T170000
DTSTAMP:20220921T183353Z
CREATED:20220921T183322Z
LAST-MODIFIED:20220921T183353Z
UID:56423-1663835400-1663866000@globalbiodefense.com
SUMMARY:VRBPAC Meeting - Rebiotix Indication for Recurrent Clostridioides difficile Infection
DESCRIPTION:The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will convene on 22 September 2022 to discuss the Biologics License Application # 125739 (BLA – 125739) from Rebiotix Inc. for a product\, Rebyota (Fecal Microbiota\, Live)\, with a requested indication to “reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent Clostridioides difficile infection.” \nFDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting\, any background material will be made publicly available at the time of the advisory committee meeting\, and additional materials will be posted on FDA’s website after the meeting. \nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. \nThe Docket Number is FDA-2022-N-1608.
URL:https://globalbiodefense.com/event/vrbpac-meeting-rebiotix-indication-for-recurrent-clostridioides-difficile-infection/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:https://www.youtube.com/watch?v=vrahKrbyJaU
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220921T120000
DTEND;TZID=America/New_York:20220921T130000
DTSTAMP:20220921T172921Z
CREATED:20220921T172727Z
LAST-MODIFIED:20220921T172921Z
UID:56416-1663761600-1663765200@globalbiodefense.com
SUMMARY:Virtual Town Hall Series - Monkeypox Test Development and Validation
DESCRIPTION:The U.S. Food and Drug Administration (FDA) will host a virtual town hall for monkeypox test developers on 21 September 2022. The purpose of these town halls is to help answer technical questions about the development and validation of tests for monkeypox. \nThe FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases\, including monkeypox . The FDA is committed to providing timely guidance to support response efforts to this public health emergency. \nThe guidance\, Policy for Monkeypox Tests to Address the Public Health Emergency\, includes policies specific to this public health emergency. \nThe FDA hosted a webinar on September 14\, 2022\, to discuss highlights of and answer questions about the final guidance. The presentation\, printable slides\, and transcript from that webinar are available at CDRH Learn under “Specialty Technical Topics”\, sub-section “Public Health Emergencies.”
URL:https://globalbiodefense.com/event/virtual-town-hall-series-monkeypox-test-development-and-validation/
CATEGORIES:Conference,Government Hosted
LOCATION:https://fda.zoomgov.com/j/1612083563?pwd=NklWOE1jUlU2dUVlNWtvQTNkdTM5UT09#success
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220921
DTEND;VALUE=DATE:20220923
DTSTAMP:20220420T212311Z
CREATED:20220420T212042Z
LAST-MODIFIED:20220420T212311Z
UID:54799-1663718400-1663891199@globalbiodefense.com
SUMMARY:Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) Meeting
DESCRIPTION:The Scientific Advisory Committee on Alternative Toxicological Methods will meet 21-22 September 2022. \nThis is a Save-the-Date posting. Further details will be made available at the National Toxicology Program website closer to the meeting date.
URL:https://globalbiodefense.com/event/scientific-advisory-committee-on-alternative-toxicological-methods-sacatm-meeting/
CATEGORIES:Conference,Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220912
DTEND;VALUE=DATE:20220914
DTSTAMP:20220830T001753Z
CREATED:20220830T001521Z
LAST-MODIFIED:20220830T001753Z
UID:56267-1662940800-1663113599@globalbiodefense.com
SUMMARY:Presidential Advisory Council on Combating Antibiotic Resistant Bacteria
DESCRIPTION:The 21st Presidential Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB) public meeting is tentatively being planned as an in-person event on September 12 and September 13\, 2022. The meeting will focus on pandemic preparedness and AMR policy. \nHighlighted topics include: \n\nUnderstanding the Human Diagnostic Communication Network (Labs\, Public Health Departments\, and Providers)\nInfection Prevention and Control for Resistant Pathogens during a Medical Surge\nLeveraging the Existing Pipeline of Available Vaccines and Therapeutics while Developing New AMR MCMs (Human)\nDeveloping New Human Diagnostics in an Emergency Situation: What’s Expected\, Needed\, and How We Get What We Need\nA Pandemic Response from a Global Perspective\nThe Agricultural Workforce: Human Health Risk and the Role of Workers as Vectors of Transmission\nThe Role of Associations in Pandemic Response and Dissemination of Information\nImpact of a Public Health Emergency on Human Antibiotic Stewardship Practices\nDiagnosing Fungal Infections and Resistance with our Current Diagnostic Capacity\nThe Role of Diagnostics in Herds: Availability\, Challenges\, and How They’re Used\nThe Federal Strategy for Animal Surveillance\, Information Sharing\, and Disseminating Guidance\nRecognizing the Pandemic: Identifying the “AMR Pandemic” within the Pandemic and Disseminating Information and Guidance\nLeveraging Current Human Antibiotic-Use-Monitoring for AMR Pandemic Surveillance\nRecognizing the Pandemic: Producer Surveillance Methods and Identifying Secondary AMR infections in Animal Production\nDevelopment of New Animal Vaccines and Understanding Federal Regulations\nUnderstanding the Animal Diagnostic Communication Network (Labs\, Producers\, and Veterinarians)\nSources of Environmental Contamination and the Potential for Surveillance\n\nThis meeting is open to the public. Members of the public can choose to attend in-person (attendance will be limited) or view the meeting via webcast. Please visit the HHS 21st Presidential Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB) website to register.
URL:https://globalbiodefense.com/event/paccarb-public-meeting-presidential-advisory-council-on-combating-antibiotic-resistant-bacteria/
LOCATION:Tysons Corner Marriott\, 8028 Leesburg Pike\, Tysons Corner\, VA\, 22182-2719\, United States
CATEGORIES:Conference,Government Hosted
END:VEVENT
END:VCALENDAR