Evaluation: 2024 March Introduction to Biologics - Food and Drug Law Institute (FDLI)

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Evaluation: 2024 March Introduction to Biologics

Evaluation: Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies

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What topics addressed at the conference did you find most valuable?

Session 1: Overview of FDA and Regulatory Processes with Patrick C. Gallagher
Session 2: Introduction to FDA Review and Approval of Biological Products with Jewell Martin
Session 3: Regulation of Biological Product/Development with Natasha V. Leskovsek
Session 4: Human Cellular and Tissue-Based Products (HCT/P), Cell Therapy and Gene Therapy with Tina Papagiannopoulos, and Matthew Piscitelli
Session 5: Biological Product Approval and Vaccines with Elizabeth Trentacost
Session 6: Biosimilar Biological Products with Krista Hessler Carver
Session 7: Post-Approval Pharmacovigilance with David L. Rosen
Session 8: Regulation of Biological Manufacturing with Seth Olson
Session 9: Regulation of Biological Product Marketing with Kathryn Culver
Session 10: Violations, Enforcement, and International Issues with David L. Chesney

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maura.schatz2024-03-06T15:41:29-05:00

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