The Regulation of Biological Product Manufacturing: An Introduction A session from FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Recorded March 5–6, 2024 The Regulation of Biological Product Manufacturing: An Introduction Examine requirements for establishment registration and listing. Learn about [...]
Post-Approval Pharmacovigilance of Biological Products: An Introduction A session from FDLI's Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Recorded March 5–6, 2024 Post-Approval Pharmacovigilance of Biological Products: An Introduction Learn the regulatory basis of post-marketing adverse event reporting and become [...]
Biosimilar Biological Products: An Introduction A session from FDLI's Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Recorded March 5–6, 2024 Biosimilar Biological Products: An Introduction Understand background and definitions of biologic and biosimilar drugs and new drug applications (NDAs) and [...]
Biological Product Approval, Vaccines, Emergency Use Authorization: An Introduction A session from FDLI's Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Recorded March 5–6, 2024 Biological Product Approval, Vaccines, Emergency Use Authorization: An Introduction Learn about the Biologics License Application (BLA) [...]
Introduction to Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy A session from FDLI's Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Recorded March 5–6, 2024 Introduction to Human Cellular and Tissue Based Products [...]
Regulation of Biological Product/Drug Development: An Introduction A session from FDLI's FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Recorded March 5–6, 2024 Regulation of Biological Product/Drug Development: An Introduction Summarize preclinical and clinical testing, sources of Good Clinical Practice [...]
Introduction to FDA Review and Approval of Biological Products A session from FDLI's Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Recorded March 5–6, 2024 Introduction to FDA Review and Approval of Biological Products Learn the statutory [...]
Overview of Biological Products Law and FDA’s Regulatory Processes A session from FDLI's Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Recorded February 27, 2024 Overview of Biological Products Law and FDA’s Regulatory Processes Learn about the role of the Food [...]
Food and Dietary Supplement Safety and Regulation Conference April 3, 2024 Washington, DC In-Person & Virtual Event Overview Agenda Details Agenda Agenda Subject to Change All Times Listed in Eastern Time Wednesday, April 3 FDLI Welcome Christine M. Simmon, President [...]
2024 FDLI Annual Conference May 15–16, 2024 Washington, DC In-Person & Virtual Event Overview Agenda Details Agenda Agenda Subject to Change All Times Listed in Eastern Time Wednesday, May 15 Christine M. Simmon, President & CEO, FDLI Winston S. Kirton, [...]
