Dear Members of the community:
I am pleased to invite you for an interesting webinar organized by our steering committee member Dr. Christina Lee of USFDA. You can pre-register and attend the webinar on "Evaluating Excipient Safety in Pediatric Population Current thinking from a BE perspective." by vising the link given below.
Evaluating Excipient Safety in Pediatric Populations: Current Thinking from a Bioequivalence Perspective - 08/08/2024 | FDA
I am confident that we all learn from this webinar.
Thank you Dr. Lee for the continued collaboration.
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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Prasad Tata M. Pharm, Ph.D., FCP
Sr. Director-PK/BE
American Regent, Inc.
East Windsor NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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