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  4. Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment | Role and Opportunities - 05/08/2024
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Event Title
Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment | Role and Opportunities
May 8 - 9, 2024


Date:
May 8 - 9, 2024
Day1:
- ET
Day2:
- ET

Location

Hybrid - Great Room, Building 31, FDA White Oak Campus & Zoom

About This Event

This co-sponsored 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 the 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 Objectives

  • Provide an overview of scientific recommendations pertaining to clinical pharmacology applications during drug development and regulatory assessment
  • Discuss the current scientific challenges and gaps in applying clinical pharmacology principles during drug development
  • Identify potential opportunities and priorities for regulatory research and scientific guidance development from a clinical pharmacology perspective

Meeting Information

The workshop is free to attend; however, registration is required for both in-person and virtual attendance. This is an in-person/virtual hybrid event. For those who wish to attend in person, the workshop will take place in the Great Room, Building 31, FDA White Oak Campus at 10903 New Hampshire Avenue, Silver Spring, MD. To register, visit the MCERSI Site.

Visit the Workshop website for more information.

For questions regarding this event, please contact OCPWorkshops@fda.hhs.gov.


Event Materials

Title File Type/Size
FDA MCERSI Guidance Workshop Agenda pdf (160.15 KB)
FDA MCERSI Guidance Workshop Bios pdf (697.34 KB)
 
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