Regulatory Science

  • Spring 2022 Regulatory Science Virtual Symposium
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    University Of Southern California

    The USC International Center for Regulatory Science in partnership with the Southern California Clinical and Translational Science Institute and the Greater Los Angeles CTSA Consortium is looking forward to welcoming you to the Spring 2022 Regulatory Science Virtual Symposium on Friday, February 4, 2022: Make Informed Decisions: Key Statistical Principles to Clinical Trail Design from 9am - 4pm

  • Georgetown University
    Howard University

    Session recordings and slide presentations are now available from the 2021 REKS Summer Series Recording: Pathway to Decentralized Clinical Trials. The goal of this series is to discuss new developments in regulations affecting decentralized clinical trials. - Introduction to Decentralized Clinical Trials" featuring Nichelle Cobb (SMART IRB) - June 16th - Options for In-Home Clinical Trial Visits"

  • Case Western Reserve University

    The CWRU School of Medicine is proud to sponsor a new non-credit course entitled "FDA Regulation in Entrepreneurship and Clinical Research Management". The goal of this course is to provide foundational knowledge in and understanding of moving your technology through the FDA approval process. The course will include a series of instructors, including both local experts as well as nationally

  • The University of Rochester's eighth annual America’s Got Regulatory Science Talent student competition, hosted by the University of Rochester Clinical and Translational Science Institute, drew the largest number of competing teams in its history. On March 4, 2021, twelve teams faced off for a chance at first prize: to present their novel regulatory science ideas to a panel of scientists from the

  • University Of Texas Hlth Sci Ctr Houston

    Clinical and research data are increasingly collected and aggregated in clinical data warehouses (CDWs). Access to these data is subject to local, state and national regulations. For multiple reasons, institutions differ in how they interpret and apply these regulations. Sometimes, inter-institutional differences are unavoidable, such as when regulations clearly require specific practices. However

  • Size matters when it comes to research, as illustrated by recent debates about whether hydroxychloroquine is effective against COVID-19. Some small studies showed it was effective while others showed it wasn’t. The studies couldn’t arrive at a definitive answer because they didn’t enroll enough patients to reach sufficient statistical “power.” More relevant results are only now beginning to emerge
  • University Of Rochester
    Georgetown University
    Competencies for regulatory science, which is a growing discipline in medical-related applications. Competencies for this complex field were identified and categorized into 11 Thematic Areas. These areas are based on a subset of the FDA’s priority areas and are accompanied by explanations of their development and broader recommendations to enrich education and training. View Full Publication
  • University Of North Carolina Chapel Hill
    Duke University
    Wake Forest University Health Sciences
    Medical University Of South Carolina
    University Of Miami School Of Medicine
    Virginia Commonwealth University
    ReGARDD provides academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics and medical devices. Investigational New Drug or Biologic Investigational Device Exemption Educational Videos ReGARDD Sponsored Events Who We Are The Regulatory Guidance for Academic Research of Drugs and
  • USC Regulatory Science Boot Camp/Symposium
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    University Of Southern California
    Join us for a day-long symposium on legal aspects of clinical trials. Hear from industry experts on topics including HIPAA and Privacy, Liability and Indemnification, Compassionate Use, and more. Attendees will receive a certificate of completion at the end of the symposium.
  • University Of Rochester
    The increased focus on precision medicine holds tremendous promise to more effectively target treatments to those individuals most likely to have a benefit. However, there are a number of regulatory science challenges to ultimately develop and utilize personalized medicine technologies and approaches. The objective of this 3rd annual Forum is to bring together federal agencies, industry
  • The Regulatory Knowledge and Support Group at the University of Southern California CTSI developed a free, online training tool on concepts of and practical approaches to clinical trial monitoring (https://sc-ctsi.org/training-education/courses/clinical-trial-monitorin…). TrialSiteNews shared a review of the tool, referring to it as "incredibly useful" and urging institutions engaged in

  • The CTSA Program’s Domain Task Forces (DTFs)* provide program members the opportunity to engage and connect across the national consortium. The DTFs advance the field of translational science through open discussions, project planning and metric assessment pertaining to five key areas: Collaboration & Engagement Informatics Lifespan Integration Methods & Processes Workforce Development
  • Omics techniques that rapidly analyze large amounts of genomic and other data from an individual cell, tissue or patient could greatly benefit precision medicine, but not without challenges. The Regulatory Science to Advance Precision Medicine Working Group, led by scientists at the University of Rochester Clinical and Translational Science Institute, held a forum in 2017 to examine those

  • Duke University
    The Regulatory Affairs Training Program is 6 weeks and consists of weekly discussions and lectures combined with independent study. There will be opportunities to review and discuss different types of regulatory submissions, including Investigational New Drug applications (INDs) and Investigational Device Exemptions (IDEs). Participants will also have the opportunity to attend an IRB meeting on
  • Technologies like 3D printing hold a lot of promise for precision medicine - even allowing scientists to grow new ears for children. As these technologies quickly advance, so does the need to regulate them. Scientists at the University of Rochester Clinical and Translational Science Institute established the Regulatory Science to Advance Precision Medicine Working Group and gathered experts from

  • Scripps Research Institute
    American Medical Association
    The Jackson Laboratory
    CME and CNE modules on the clinical applications of genetic testing How can genetics be used in clinic with my patients? Can genetic information really improve outcomes? Genetic testing is constantly changing. How can I keep up? Precision Medicine for Your Practice is an educational program being developed by Scripps Research Translational Institute (Scripps), the American Medical Association (AMA