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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2023 1:00 PM - Feb 09, 2023 12:35 AM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Session 6: Signal Detection

Session Chair(s)

Mengchun  Li, MD, MPA

Mengchun Li, MD, MPA

Senior Director, Clinical Research, Infectious Disease

Merck & Co., Inc., United States

Barbara  Hendrickson, DrMed, MD

Barbara Hendrickson, DrMed, MD

Clinical Associate, Pediatric Infectious Diseases

University of Chicago, United States

Safety monitoring and signal detection are essential components in drug development. Thorough reviews of clinical trial safety data at regular intervals are critical to characterize the drug safety profile beginning early and continuing through drug development to protect patient safety and, ultimately, public health. Visualization approaches to evaluate safety data continue to evolve, taking into account how the human brain processes visual information and the advancement of interactive programing tools. The Interactive Safety Graphics (ISG) Task Force of the American Statistical Association Biopharmaceutical Safety Working Group has assembled a multidisciplinary team of experts in a variety of domains to develop the next generation of open-source visual analytical tools for safety data based on these technical advances. In this session, we will introduce four interactive visualization tools developed by the ISG taskforce: Hepatic Explorer, QT Explorer (cardiac safety, in collaboration with Cardiac Safety Research Consortium, CSRC), Renal Explorer, and AE volcano plot to address common safety topics during drug development. The tools have the capacity to monitor safety data at an aggregated level, as well as to drill down to single patient level. Also, the tools can be applied to facilitate Aggregated Safety Assessment Planning (ASAP) process, in which case grouped terms shall be applied (such as FMQ or SMQ, or company specific grouped terms) to address each safety topics of interest with the corresponding medical concept. Successful user cases will be illustrated. An expert hepatologist and cardiologist will be invited as panelists to discuss the evaluation of hepatic or QTc signals in clinical development programs.

Learning Objective :
  • Recognize how data visualization can assist in safety assessment and signal detection
  • Describe the importance of multidisciplinary collaboration in data visualization and signal detection
  • Apply novel open-source interactive visualization tools for safety assessment
  • Discuss how to evaluate hepatic and QTc safety signals in clinical development
  • Integrate visualization tools and ASAP process in signal detection

Speaker(s)

James  Buchanan, PharmD

Introduction to the ISG Visualization Tools and Their Value in Identifying Adverse Effects and Signal Detection

James Buchanan, PharmD

Covilance LLC, United States

President

Boaz  Mendzelevski, MD

Panelist

Boaz Mendzelevski, MD

Cardiac Safety Consultants Ltd., United Kingdom

Consultant Cardiologist

Cynthia  McShea, MPH

Leveraging the ISG Tool and ASAP Process: User Case Sharing

Cynthia McShea, MPH

UCB Biosciences, United States

Head, Safety Statistics

Paul  Hayashi, MD, MPH

Panelist

Paul Hayashi, MD, MPH

FDA, United States

Physician Lead, DILI Team, Division of Hepatology and Nutrition,OND, CDER

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