Event
Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment
Wednesday, May 8, 2024
9:00 a.m.-2:30 p.m.
Building 31, FDA Great Room FDA White Oak Campus
cersi@umd.edu
Location Address
10903 New Hampshire Avenue, Silver Spring, MD 20903
About This Event
This public workshop will be hosted by the FDA Office of Clinical Pharmacology (OCP) and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). The purpose of this workshop is to serve as a mechanism to engage with the public to share information on existing clinical pharmacology guidances and identify emerging scientific topics that might benefit from the development of scientific research and recommendations.
Background
At every step of drug development, clinical pharmacology is applied to generate, evaluate, and use knowledge of drug disposition, pharmacology, and disease biology to progressively reduce regulatory uncertainty and inform public health decision-making. Clinical pharmacology principles form the basis of dosage selection and optimization and promote therapeutic individualization by translating the knowledge of patient diversity into clinical recommendations for safe and effective use of medications. Therefore, having clear, pragmatic, and contemporary scientific recommendations to inform drug development and regulatory assessment is critical for the successful and efficient development of therapeutics that protect and promote public health. Developing new or revising existing guidance documents, especially in the broad field of clinical pharmacology, requires a unique and integrated approach centered around multistakeholder partnerships.
Workshop goals
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Provide an overview of scientific recommendations pertaining to clinical pharmacology applications during drug development and regulatory assessment.
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Discuss the current scientific challenges and gaps in applying clinical pharmacology principles during drug development.
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Identify potential opportunities and priorities for regulatory research and scientific guidance development from a clinical pharmacology perspective.
Registration
Registration is free. All interested parties are encouraged to register early.
This workshop will be held on-site and in virtual format. Registration is required for both in-person and virtual attendance. Registration will be available until 5:00 PM ET on Friday, May 3, 2024 for in-person attendance. Registrants will receive confirmation when they register. The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email FDAGreatRoom@fda.hhs.gov at least 7 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.
To register, please use this link
To view the agenda, please use this link
To view the speaker bios, please use this link
On-Site Attendance
For information related to on-site attendance, please refer to FDA.gov.
https://www.fda.gov/about-fda/visitor-information/public-meeting-information
Virtual Attendance (Zoom Webinar)
This meeting will be available for virtual viewing on the days of the meeting via Zoom. All information will be sent to attendees prior to the workshop. If you are unable to download Zoom, you can also use the browser version of Zoom for viewing this workshop.
