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  4. Evaluating Excipient Safety in Pediatric Populations: Current Thinking from a Bioequivalence Perspective - 08/08/2024
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Conference | Virtual

Event Title
Evaluating Excipient Safety in Pediatric Populations: Current Thinking from a Bioequivalence Perspective
August 8, 2024

Date:
August 8, 2024
Time:
11:00 a.m. - 12:00 p.m. ET

About This Event

The Food and Drug Administration (FDA), in collaboration with the American Association of Pharmaceutical Scientists (AAPS), proudly present a webinar that explores the critical intersection of excipient safety and pediatric health. Our expert speakers will delve into the current thinking in evaluating excipient safety for the pediatric population for generic drug products.

Learn more about the critical role excipient safety evaluation in the pediatric population plays in the bioequivalence assessment for Abbreviated New Drug Applications. Experts from FDA and AAPS will explore the current thinking through a risk-based approach currently being piloted.   Real-world case studies will highlight the challenges and opportunities in ensuring excipient safety for pediatric patients. Each presentation will provide valuable insights and practical takeaways for anyone involved in generic drug development, pediatric health care, or excipient safety evaluation.

Don't miss this opportunity to stay ahead of the curve and ensure the safety and well-being of pediatric patients!

Key Takeaways:

  • Understand the current state of excipient safety evaluation in pediatric populations
  • Learn about the risk-based approach being piloted in the Office of Generic Drugs
  • Gain insights from case studies and expert discussions

Who Should Attend:

  • Regulatory affairs professionals
  • Pharmaceutical scientists and researchers
  • Pediatric health care professionals
  • Anyone involved in generic drug development or excipient safety evaluation

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