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X-WR-CALNAME:Global Biodefense
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X-WR-CALDESC:Events for Global Biodefense
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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
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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:
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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
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230427T090000
DTEND;TZID=America/New_York:20230427T130000
DTSTAMP:20230421T193407Z
CREATED:20230421T163659Z
LAST-MODIFIED:20230421T193407Z
UID:56966-1682586000-1682600400@globalbiodefense.com
SUMMARY:Recombinant Protein-Based COVID-19 Vaccines Workshop
DESCRIPTION:The Biomedical Advanced Research and Development Authority (BARDA) and FDA will host a virtual workshop titled Recombinant Protein-Based COVID-19 Vaccines April 27\, 2023\, from 9:00 am EDT to 1:00 pm EDT. \nThe goals of the workshop are to provide a forum for product sponsors to discuss progress and technical challenges in the manufacturing when changing strain composition to currently circulating variants of SARS-CoV-2; and an open forum for collaborative discussions to facilitate advancement of recombinant protein-based COVID-19 vaccines. \nHighlighted topics include: \n\nPandemic preparedness\, target product profile\, timelines\, and the need for continued investment\nEpidemiology\, disease burden\, continued need for COVID-19 vaccines\nFeatures of novel vaccines\, need for next generation vaccines\nOvercoming challenges to address strain updates and pandemic readiness\nRecombinant COVID-19 vaccine presentations from Novavax\, Sanofi\, SK Bioscience\, Dyadic\, Biological E\, and Intravacc\n\nPlease visit the FDA’s Recombinant Protein-Based COVID-19 Vaccines Workshop site to register to attend online.
URL:https://globalbiodefense.com/event/fda-recombinant-protein-based-covid-19-vaccines-workshop/
CATEGORIES:Government Hosted
LOCATION:https://fda.zoomgov.com/meeting/register/vJIsd-GvrDgqGKQjMEzpDtzTCvGTY4xmZxk
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230427T120000
DTEND;TZID=America/New_York:20230427T163000
DTSTAMP:20230421T193340Z
CREATED:20230421T180232Z
LAST-MODIFIED:20230421T193340Z
UID:56980-1682596800-1682613000@globalbiodefense.com
SUMMARY:Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
DESCRIPTION:The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public listening meeting on 27 April 2023 to solicit input on methods and approaches (e.g.\, use of real-world evidence (RWE)\, registries) for capturing post approval safety and efficacy data for cell and gene therapy products. \nThe rapid pace of innovation for cell and gene therapy products holds promise for transforming medicine and creating treatment options for patients living with difficult\, rare\, and often incurable diseases. With an increasing number of cell and gene therapy products in development and the potential for more of these treatments to become available to patients in the future\, it is important to understand the full spectrum of long-term effects and collect accurate\, timely\, and comprehensive data to ensure these products remain safe\, effective\, and of high quality. The FDA is seeking input on methods\, approaches\, logistics\, privacy concerns\, and other aspects related to efficacy and safety data collection in the post-approval setting for cell and gene therapies. \nThis is a virtual public listening meeting and will be held via Zoom. The meeting is free and open to the public; however\, registration is required. Early registration is recommended. \nRegistration will close on Wednesday\, April 26\, 2023 at 11:59 p.m. ET. A recording and other relevant meeting materials will be posted online following the event. \nPlease visit the FDA CBER OTP Public Listening Meeting — Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products site to register.
URL:https://globalbiodefense.com/event/capturing-post-approval-safety-and-efficacy-data-on-cell-and-gene-therapy-products/
CATEGORIES:Government Hosted
LOCATION:
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