DIA 2024 Global Annual Meeting

Join us at the premier life sciences conference, celebrating our 60th anniversary! Discover 180+ sessions on Cell and Gene Therapy, Decentralized Clinical Trials, AI, ICH, and more. Get ready to tackle challenges, improve skills, network, and drive change for healthcare at DIA2024.

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Interactive Safety Graphics in the Regulatory Decision-Making Process

Session Chair(s)

Greg Ball, PhD

Safety Data Scientist

ASAPprocess, United States

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 Objective : 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.

Speaker(s)

Panelist

Scott Proestel, MD

FDA, United States

Senior Medical Officer, ODES, OND, CDER, FDA

Panelist

Y. Veronica Pei, MD, MEd, MPH

FDA, United States

Acting Associate Director, Biomedical Informatics and Regulatory Review Science

Panelist

Glen Wright Colopy, PhD, MSc

Wildfell Software, United States

Head of Data Science and Statistics

Panelist

David Nahamya

Uganda National Drug Authority, Uganda

Secretary to the Authority

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DIA 2024 Global Annual Meeting

Interactive Safety Graphics in the Regulatory Decision-Making Process

Session Chair(s)

Greg Ball, PhD

Learning Objective : 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.

Speaker(s)

Panelist

Panelist

Panelist

Panelist

Be informed and stay engaged.