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X-WR-CALDESC:Events for Global Biodefense
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DTSTART;VALUE=DATE:20211103
DTEND;VALUE=DATE:20211105
DTSTAMP:20210812T192722Z
CREATED:20210812T192722Z
LAST-MODIFIED:20210812T192722Z
UID:49489-1635897600-1636070399@globalbiodefense.com
SUMMARY:BARDA Industry Day 2021 – BID2021
DESCRIPTION:This BARDA Industry Day 2021 Virtual Event will be held 3-4 November 2021. \nThis annual gathering of more than 1300 stakeholders from the public and private sector provides an opportunity to increase understanding of the U.S. government medical countermeasure priorities and funding goals; interact with BARDA and ASPR staff; and showcase innovations. \nInnovators may apply for limited openings to present during Lightning Talks sessions. Lightning Talks are for individuals\, academic institutions\, pharmaceutical companies\, biotech\, and other industry innovators to showcase their innovative technologies. \nTo submit your application for the Lightning Talks\, please enter the requested information and provide a brief (maximum 500 words) summary of your proposed presentation\, with one optional PowerPoint slide\, by 16 August. \nVisit the BARDA Industry Day website for more information. \n  \n 
URL:https://globalbiodefense.com/event/barda-industry-day-2021-bid2021/
CATEGORIES:Conference,Government Hosted,Industry Day
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2021/08/bid-2021-barda-industry-day.jpg
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DTSTART;VALUE=DATE:20211104
DTEND;VALUE=DATE:20211106
DTSTAMP:20211014T233809Z
CREATED:20211014T233450Z
LAST-MODIFIED:20211014T233809Z
UID:50256-1635984000-1636156799@globalbiodefense.com
SUMMARY:NIH 2021 Synthetic Biology Consortium
DESCRIPTION:The 2021 Annual Synthetic Biology Consortium Meeting will take place in virtual format from November 4-5\, 2021. \nThe 2021 Synthetic Biology Consortium Meeting will facilitate networking and collaboration among synthetic biology investigators. Attendees can use this meeting to collaborate with each other on current topics in synthetic biology and engage with NIH program directors. \nHighlighted presenters and panelists include: \n\nKaren Elkins\, FDA\, Center for Biologics Evaluation and Research\nMichelle Bond\, NIGMS\, Division of Pharmacology\, Physiology\, and Biological Chemistry\nTuba Fehr\, NICHD\, Development Biology and Structural Variation Branch\nTim Lu\, Massachusetts Institute of Technology\nGary Lee\, Senti Biosciences\nStephanie Morris\, NHGRI\, Division of Genome Sciences\nBrigitte Sanders\, NIAID\, Division of AIDS\nHye-Sook Kim\, NCCIH\, Basic and Mechanistic Research\nTatjana Atanasijevic\, NIBIB\, Division of Applied Science and Technology (Bioimaging)\nParijat Bhatnagar\, SRI International\nJoshua Leonard\, Northwestern University\nTara Deans\, The University of Utah\nDave Rampulla\, NIBIB\, Division of Discovery Science and Technology (Bioengineering)\nRahul Thakar\, NHLBI\, Advanced Technologies and Surgery Branch\nRyan Richardson\, NINDS\, Office of the BRAIN Director\nJerry Li\, NCI\, Structural Biology and Molecular Applications Branch\nKelly Crotty\, NCI\, Center for Strategic Scientific Initiatives\nJiahe Li\, Northeastern University\nTal Danino\, Columbia University\nAndrew Ellington\, University of Texas at Austin\nOphelia Venturelli\, University of Wisconsin-Madison\n\nPlease visit NIH’s 2021 Synthetic Biology Consortium meeting site for more information. \n 
URL:https://globalbiodefense.com/event/nih-2021-synthetic-biology-consortium/
CATEGORIES:Conference,Government Hosted,Webinar-Webcast
LOCATION:https://www.zoomgov.com/meeting/register/vJItfu-hpzIiHqmy-7yogDu9ImlF2Lfd0iE
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20211116T090000
DTEND;TZID=America/New_York:20211116T160000
DTSTAMP:20211111T192222Z
CREATED:20211104T181912Z
LAST-MODIFIED:20211111T192222Z
UID:50927-1637053200-1637078400@globalbiodefense.com
SUMMARY:Enhanced Drug Distribution Security at the Package Level
DESCRIPTION:The FDA will hold a virtual public meeting on November 16\, 2021\, on enhanced drug distribution security at the package level. \nThe purpose of this public meeting is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to provide input to FDA on the implementation of the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) that go into effect in 2023. \nFDA requests that stakeholders prepare comments responding to the following questions for one or more of the topics listed below: \n\nHow is implementation of the 2023 enhanced system requirements progressing for your organization?\nWhat challenges is your organization facing?\nAre the proposed recommendations in FDA’s guidance on enhanced drug distribution security at the package level helpful to achieve compliance with 2023 enhanced system requirements? If not\, what additional information would be useful?\nAre there areas in which FDA could provide more clarity?\n\nTopics\n\nEnhanced Drug Distribution Security\n\nSystem Attributes\nAggregation\, Inference\, and Physical Security Features\n\n\nSystem Structure\n\nData Architecture\nAdoption of Data and System Security\nProtecting Confidential Commercial Information and Trade Secrets\nSystem Access and Data Retrieval\n\n\nEnhanced Product Tracing\n\nSerialized Transaction Information and Data Exchange (Incorporation of the Product Identifier into Product Tracing Information)\nResponsibilities of the Selling and Buying Trading Partners with regard to the Product Tracing Information\nHandling Aggregation Errors and Other Discrepancies\n\n\nGathering of Relevant Product Tracing Information\nEnhanced Verification\n\nVerification of Distributed Product\nVerification of Saleable Return Product\nAlerts for Illegitimate Product\n\n\nTrading Partner Readiness\n\nYour organization’s overall readiness for implementation\nComponents that your organization is furthest along in developing\, including the components being prioritized and the components that are easier or more challenging to implement\n\n\n\nAdditional Information\n\nEnhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Draft Guidance for Industry\nFDA Webinar on October 5\, 2021: Enhanced Drug Distribution Security in 2023 Under the DSCSA
URL:https://globalbiodefense.com/event/enhanced-drug-distribution-security-at-the-package-level/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
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DTSTART;TZID=America/New_York:20211130T090000
DTEND;TZID=America/New_York:20211130T170000
DTSTAMP:20211111T191610Z
CREATED:20211111T191610Z
LAST-MODIFIED:20211111T191610Z
UID:50925-1638262800-1638291600@globalbiodefense.com
SUMMARY:Antimicrobial Drugs Advisory Committee (AMDAC) Meeting
DESCRIPTION:The FDA Antimicrobial Drugs Advisory Committee (AMDAC) will convene on 30 November 2021 to discuss Merck and Ridgeback’s request for emergency use (EUA) of molnupiravir oral capsules for treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. an investigational antiviral drug to treat COVID-19. \nFDA intends to make background material available to the public no later than two (2) business days before the meeting. \nBackground material and the link to the online teleconference meeting room will be available at 2021 Meeting Materials\, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee. \nPublic Participation Information\nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. \nFDA is establishing a docket for public comment on this meeting. The docket number is FDA-2021-N-0758. The docket will close on November 29\, 2021. Submit either electronic or written comments on this public meeting by November 29\, 2021. \nComments received on or before November 15\, 2021\, will be provided to the committee(s). Comments received after that date but by November 29\, 2021\, will be taken into consideration by FDA. \nLearn more at the FDA meeting announcement website. \n  \n 
URL:https://globalbiodefense.com/event/antimicrobial-drugs-advisory-committee-amdac-meeting/
CATEGORIES:Government Hosted
LOCATION:
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