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Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment

8 May 2024 @ 9:00 am - 2:30 pm

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 optimisation and promote therapeutic individualisation 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

  1. Provide an overview of scientific recommendations pertaining to clinical pharmacology applications during drug development and regulatory assessment.

  2. Discuss the current scientific challenges and gaps in applying clinical pharmacology principles during drug development.

  3. Identify potential opportunities and priorities for regulatory research and scientific guidance development from a clinical pharmacology perspective.

AGENDA

Click here to see the full agenda.

REGISTRATION

Registration is free.  All interested parties are encouraged to register early. Please click here to register.

Click here to learn more.