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Monday, June 17 • 2:15pm - 3:15pm
#130: Interactive Safety Graphics in the Regulatory Decision-Making Process

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-530-L04-P; CME 1.00; RN 1.00

Different visionary options may lead to a different look and feel to clincial study reports (CSRs) and submissions:
  • Broader use of interactive displays in submissions
  • Sponsor provides interactive package(s)
  • Regulators/sponsors use their own interactive package(s)


    • Let’s continue the discussion on how best to collaborate on interactive safety review strategy and development.

    Learning Objectives

    Identify the impact of interactive displays on submission content and the review process including the clinical study report (CSR) and trial data submission, use of review software, and answering information requests.

    Chair

    Greg Ball, PhD

    Speaker

    Panelist
    Scott Proestel, DrMed, MD

    Panelist
    Y. Veronica Pei, MD, MEd, MPH

    Panelist
    Glen Wright Colopy, PhD, MSc

    Panelist
    David Nahamya


    Speakers
    avatar for Greg Ball

    Greg Ball

    Safety Data Scientist, ASAPprocess, United States
    Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →
    avatar for Glen Colopy

    Glen Colopy

    Head of Data Science and Statistics, Wildfell Software, United States
    Glen Wright Colopy is the Head of Data Science & Statistics at Wildfell, a startup specializing in custom software and data science solutions for the biotech and life science industries. Glen's day-to-day work is as a hands-on full stack data science contributor, focused on helping... Read More →
    DN

    David Nahamya

    Secretary to the Authority, Uganda National Drug Authority, Uganda
    David was born in 1967 to Mr. and Mrs. Kihumuro; Ntungamo District, Western Uganda. He is known for being an influential person for positive change and leads with confidence. David is a graduate of MSc. Pharmaceutical Sciences - University of Havana; has PGD in Management - Uganda... Read More →
    avatar for Y. Veronica Pei

    Y. Veronica Pei

    Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States
    Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role... Read More →
    avatar for Scott Proestel

    Scott Proestel

    Senior Medical Officer, ODES, OND, CDER, FDA, FDA, United States
    Scott Proestel, MD, is a Senior Medical Officer on the Biomedical Informatics and Regulatory Review Science Team at the US FDA’s Center for Drug Evaluation and Research. He completed his internal medicine training at Johns Hopkins Hospital and obtained his medical degree from Columbia... Read More →

    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      11: Statistics-Data Science, Forum |   01: ClinSafety-PV, Forum