A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
Biosimilar Products: An Introduction to Approval Pathways
Upcoming Courses
This web seminar provides a review of FDA requirements for approval of a Biosimilar product. The Biosimilar product approval pathway and the underlying Scientific/Quality/Regulatory principles involved are covered, along with guidelines for each aspect of biosimilar research. Additionally, the FDA Stepwise Approach to demonstrating Biosimilarity will be discussed, as well as general considerations on animal/clinical/in vitro studies. Finally, FDA’s Totality-of-the-Evidence approach will also be covered.
- Explore the Biologics Price Competition and Innovation Act (BPCI Act)
- Describe what a Biosimilar product is
- Describe the Biosimilar approval pathway
- Review FDA Guidances on Biosimilar products
- Explore the Totality-of-the-Evidence approach the FDA is using
- Regulatory Affairs Personnel
- Research Personnel
- Clinical Personnel
- Nonclinical Personnel
- Manufacturing Personnel
- Personnel who require a general understanding of Biosimilar products
Albert A. Ghignone, M.S., R.A.C.
Click here for complete trainer biographies
$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 3 hours (0.3 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-13-023-L01-P. Released: 2/13.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
