Webcast
Event Title
FDA Grand Rounds: Applied Regulatory Research to Address the Ongoing Opioid Crisis
October 12, 2023
- Date:
- October 12, 2023
- Time:
- 12:00 PM - 1:00 PM ET
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About the Speakers
Lidiya Stavitskaya, Ph.D.
Pharmacokineticist
Division of Applied Regulatory Science
Office of Clinical Pharmacology, Office of Translational Sciences
Center for Drug Evaluation and Research (CDER)
Dr. Stavitskaya received her Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore in 2011. She joined Division of Applied Regulatory Sciences (DARS) in Center for Drug Evaluation and Research (CDER), as a Computational Toxicologist in 2014. Dr. Stavitskaya has extensive research experience in the areas of medicinal chemistry and regulatory computational pharmacology and toxicology. Dr. Stavitskaya’s current focus is to improve FDA’s ability to predict drug safety issues and to expand the use of chemical informatics and predictive modeling in safety assessment.
Zhihua Li, Ph.D.
Pharmacokineticist
Division of Applied Regulatory Science
Office of Clinical Pharmacology, Office of Translational Sciences
Center for Drug Evaluation and Research (CDER)
Dr. Zhihua Li is the Principal Investigator of several computational biology and quantitative systems pharmacology projects at Division of Applied Regulatory Sciences (DARS). He has been leading the in silico workstream under a global effort to develop a new regulatory paradigm for cardiac safety. He also led the development of translational models to evaluate the effects of opioids and opioid antagonists that informed the development and regulatory decision making for some recent opioid antagonists products.
About the Presentation
According to preliminary data released by the Centers for Disease Control and Prevention, the nation set a new record of over 109,000 deaths from illicit and prescription drug overdose in 2022. This presentation will focus on computational methods that have been developed to rapidly assess if newly emerging opioids are a risk to public safety and to evaluate dosing strategies for using opioid receptor antagonists.
Event Materials
Activity Announcement for FDA Grand Rounds – October 12, 2023
Webcast Recording
Learning Objectives
- Describe the different computational methodologies that are being applied at the FDA to address the ongoing opioid crisis.
- Explain how model-informed approaches have facilitated assessment of newly emerging opioids and opioid antagonist drug development.
Registration
FDA employees MUST register in BOTH the following:
- Zoom Registration *Once you have registered in ZOOM, you will receive a confirmation email with the webcast URL
- LMS Registration
Non-FDA employees must register in:
- Zoom Registration *Once you have registered in ZOOM, you will receive a confirmation email with the webcast URL
After Zoom webcast registration, you will receive a link via email to access the live webinar. You must log in with the username and password created when you registered. Please pre-register at least two days before the event to ensure you receive the access link and outlook invitation for the session.
For technical assistance please contact: Sharron.Watson@fda.hhs.gov