Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA Recorded January 30, 2024 | On-Demand Materials Tuesday, January 30 Welcome and Course Overview Khara L. Minter, Assistant Director, Training Programs, FDLI I. Is My Digital Health Product a Medical Device [...]
Topic Suggestions Is there a specific topic you would like to see addressed in a future FDLI event? If so, please share your suggestions on our online portal.
Recorded March 14, 2024 | Washington, DC
Topic Suggestions Is there a specific topic you would like to see addressed in a future FDLI event? If so, please share your suggestions on our online portal.
Topic Suggestions Is there a specific topic you would like to see addressed in a future FDLI event? If so, please share your suggestions on our online portal.
An Introduction to Violations, Enforcement, and International Issues in Biologics and Biosimilars A session from FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Recorded March 5–6, 2024 An Introduction to Violations, Enforcement, and International Issues in Biologics and Biosimilars Learn [...]
The Regulation of Biological Product Marketing: 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 Marketing: An Introduction Learn the legal and regulatory requirements surrounding communications about [...]
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 [...]
