Virtual

Apr 22, 2025 11:30 AM - Apr 22, 2025 1:00 PM

(US Eastern Standard Time)

Implementing an Independent Assessment Entity for IND Safety Reporting

In this webinar, we will have four speakers – representing consultants, CROs, industry, and the FDA – to discuss, from different perspectives, the challenges, strategies, and technologies for meeting the spirit of the FDA IND Safety Reporting final rule.

Overview

CIMS is pioneering Dynamic Data Monitoring with a vision of reshaping the future of clinical trials. We are empowering pharmaceutical and biotech companies to bring drugs to market sooner, saving millions of dollars on clinical trials and bringing much-needed therapies to patients faster.


In 2010, the FDA released the final rule for investigational new drug (IND) safety reporting requirements for human drug and biological products. A 2021 draft guidance offers more detailed information on the responsibilities of sponsors regarding the monitoring and reporting of safety data, emphasizing proactive safety management and the need for a systematic approach to safety surveillance. The draft guidance underscores the importance of assessing safety information not only on a case-by-case basis but also in the context of aggregate data from all sources.

Featured topics

  • Safety Strategy Guiding the Technical Implementation - Greg Ball, PhD, Safety Data Scientist, ASAP process
  • Dynamic Safety Monitoring - Tai Xie, PhD, Founder and CEO, CIMS
  • Clinical decision-making from an industry perspective - Barbara Hendrickson, DrMed, MD, Clinical Associate, Pediatric Infectious Diseases, University of Chicago
  • Clinical decision-making from a regulatory perspective - Scott Proestel, MD, Vice President, Medical Informatics
  • Q&A / Panel Discussion (30 minutes)

Who should attend?

  • Clinical safety professionals
  • Medical experts
  • Safety data scientists
  • Epidemiologists
  • Regulatory scientists

    Have an account?

    Be informed and stay engaged.

    Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.