This course provides a comprehensive approach to understanding FDA requirements for approval of a Biosimilar Product. Participants receive a foundation of knowledge about the Biosimilar Product approval pathway and the underlying Scientific/Quality/Regulatory principles involved. Guidelines for each aspect of research are provided. The FDA Stepwise Approach to demonstrating Biosimilarity will be discussed. General considerations on animal/clinical/in vitro studies will be reviewed, as well as the FDA’s Totality-of-the-Evidence approach.
- Explore the BPCI Act
- Describe What a Biosimilar Product is
- Describe the Biosimilar Approval Pathway
- Review FDA Guidance’s on Biosimilar Products
- Explore the “Totality of the Evidence” Approach FDA is Using
- Explain the FDA’s Recommended Step-Wise Approach for Biosimilar Products
- Navigate Meetings with FDA Relative to Biosimilar Products
- Discuss the Quality/Scientific Considerations for Biosimilar Products
Albert A. Ghignone, M.S., R.A.C.
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Day One: 8:30 a.m. – 5:00 p.m.
- FDA Law and History
- Biologics Price Competition and Innovation Act
- Regulatory Strategy
- FDA Meetings
- Biologics Price Competition and Innovation Act; Q&A
Day Two: 8:30 a.m. – 5:00 p.m.
- Biosimilar Product: Scientific Considerations - Biosimilar vs. Interchangeable; Stepwise Approach; Totality-of-the-Evidence; Animal Studies; Clinical Studies; Postmarket Requirements
- Biosimilar Product: Quality Considerations - Factors in Assessing Whether Products are Biosimilar; Expression System; Manufacturing Process; Reference Product; Finished Drug Product; Stability
There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.
- Q&A sessions
- Disussions sessions
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 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# 0778-0000-12-055-L01-P. Released 8/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.