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  4. Overview: Clinical Pharmacology Considerations for Neonatal Studies - 02/15/2023
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Virtual

Event Title
Overview: Clinical Pharmacology Considerations for Neonatal Studies
February 15, 2023


Date:
February 15, 2023
Time:
1:00 PM - 2:00 PM ET


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ABOUT THIS WEBINAR

In this webinar, FDA will discuss:

  • An overview of the current status and the gaps related to the inclusion of neonates in drug development
  • Clinical pharmacology considerations for planned studies in neonates
  • General pharmacokinetic, pharmacodynamic, and pharmacogenomic considerations for clinical pharmacology studies in neonates
  • Unique clinical and study design considerations for studying neonates
  • Innovative approaches that can be incorporated into study design to address unique challenges in neonates

TOPICS COVERED

  • Defining neonatal subpopulations that can be used for study design and study results reporting
  • Clinical pharmacology and study design considerations for neonatal studies
  • Innovative approaches to study design and analysis to address unique challenges in performing clinical trials in neonates

LEARNING OBJECTIVES

  • Describe how neonatal subpopulations can be defined for the purposes of study design and reporting
  • Discuss clinical pharmacology considerations for clinical studies in neonates for drug development
  • Discuss innovative approaches that can be incorporated into study design to address unique challenges in conducting neonatal studies

INTENDED AUDIENCE

  • Regulatory science and regulatory affairs professionals working on submission of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications who are planning to conduct clinical studies in neonatal populations
  • Researchers working on clinical pharmacology and clinical studies in the pediatric population including neonates
  • Consultants focused on clinical pharmacology and clinical studies in the pediatric population including neonates
  • Clinical research coordinators involved in studies conducted in the pediatric population including neonates
  • Healthcare professionals specializing in pediatrics including neonates
  • Foreign regulators

FDA SPEAKERS

A Pediatric Research Imperative: Addressing Neonates in Drug Development
Dionna Green
Director
Office Pediatric Therapeutics (OPT) | Office of the Commissioner (OC) | FDA

Clinical Considerations for Neonatal Drug Development
An Massaro
Supervisory Medical Officer
OPT | OC | FDA

Clinical Pharmacology of Neonates and Considerations for Study Design
Elimika Pfuma Fletcher
Policy Lead and Senior Clinical Pharmacologist
Office of Clinical Pharmacology (OCP) | Office of Translational Sciences (OTS) | CDER | FDA

FDA RESOURCES

CONTINUING EDUCATION

This webinar has been approved for 1.00 contact hour of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. After the course concludes, that day's attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim codes.

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This webinar has been:

  • pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

  • To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
  • Please contact [email protected] for all technical questions.
  • If you encounter any technical issues before or during the event, please visit the Technical Issues Support.
  • Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.

 

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