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  • In-Depth Look at Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs

    Virtual Event

    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: Select case studies on various bioavailability (BA) related subtopics (e.g. pharmacodynamic (PD) endpoints, endogenous compound Narrow Therapeutic Index (NTI), biowaivers). Bioavailability

  • Responding to the Climate Change and Health Crisis: A Framework for Academic Public Health

    Virtual Event

    The Association of Schools and Programs of Public Health (ASPPH) will host a framework launch webinar on Responding to the Climate Change and Health Crisis from 2:00 – 3:00 PM ET on Wednesday, October 26, featuring an expert panel that will discuss some of the challenges and opportunities it identifies. The framework examines climate change

  • Best Practices: Modeling Approaches to Support Generic Product Development

    Virtual Event

    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 The purpose of this two-day workshop is to discuss and illustrate how generic product developers can utilize modeling approaches in conjunction with in vitro

  • Public Health Workforce Calculator: Staffing up to Achieve Foundational Services

    Virtual Event

    In 2021, an analysis of the public health workforce found that state and local governmental public health departments need an 80% increase in their workforce to provide a minimum set of public health services to the nation. In response to this gap, the Public Health National Center for Innovations at PHAB, de Beaumont Foundation, and

  • Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting

    Virtual Event

    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

  • AACC Middle East

    Grand Hyatt Dubai Riyadh Street, Sheikh Rashid Road, Dubai, United Arab Emirates

    AACC Middle East will be held 5-6 November in Dubai, UAE in partnership with Life Dx. The event that brings the latest in laboratory medicine to the Middle East region and showcases diagnostic innovations at a dynamic exposition. The conference covers a range of timely topics from infectious diseases to big data to prenatal emerging

  • Considerations and Approaches for Obese Patient Populations in Drug Development Studies

    Virtual Event

    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. The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI)

  • FDA Review: EUA for Oral Sabizabulin for High-Risk COVID-19 Patients

    Virtual Event

    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. Sabizabulin

  • 70th IAEM Annual Conference & EMEX

    Savannah International Trade and Convention Center 1 International Drive , Savannah, GA, United States

    The 70th IAEM Annual Conference & EMEX will be held 11-17 November 2022 in Savannah, Georgia. The program features more than 150 speakers providing plenaries and breakout sessions under the umbrella theme, “Emergency Management Unmuted.” In addition, All DHS/FEMA pre-/post-conference training courses, the IAEM Leadership Symposium, IAEM K-12 Workshop, and the Ascenttra Advanced Exercise Design