Dear Fellow Pharmaceutical Scientists;
I am pleased to invite you all to the May 2024, Bioequivalence and Bioavailability Sciences community on May 01, 2024. We are fortunate that Dr. Diana Vivian and Dr. Angelique Besold agreed to speak on two important topics. Please plan on attending this interesting webinar and I request each one of you to circulate this announcement among your peer groups and interested colleagues.
Bioequivalence Bioavailability Sciences Community May 1, 2024, webinar
May 1, 2024, 11:00 AM – 12:00 PM (America/New York)
Topic 1: “Complex Generic Drug Product Changes: Bioequivalence Considerations and Case Studies”
Speaker: Dr. Diana Vivian, Associate Division Director, Division of Bioequivalence II, USFDA
Abstract: Recommendations for data needed to support changes to complex generic drug products are generally not covered in published Scale-Up and Post Approval Changes (SUPAC) guidances. This talk will highlight case studies of previous considerations and recommendations for complex generic drug product changes.
Topic 2: “Overview of FDA’s Scale-up and Post-Approval Changes (SUPAC) Guidance Perspectives”
Speaker: Dr. Angelique Besold, Pharmacologist, Division of Bioequivalence II, USFDA
Abstract: This talk outlines the current bioequivalence recommendations for studies to be submitted to the FDA for post-approval changes made to immediate release and modified release solid oral dosage forms.
Mark your Colanders and join the webinar on May 1, 2024, using information given below
Bioequivalence Bioavailability Sciences Community May 1, 2024, webinar
May 1, 2024, 11:00 AM – 12:00 PM (America/New York)
Please join my meeting from your computer, tablet or smartphone. https://meet.goto.com/141602341
You can also dial in using your phone. Access Code: 141-602-341
United States: +1 (571) 317-3122
Join from a video-conferencing room or system.
Meeting ID: 141-602-341
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Or dial directly: [email protected] or 67.217.95.2##141602341
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