Biosimilar (Generic) Biologics In The USA: Approval Pathway

Biosimilar (Generic) Biologics In The USA: Approval Pathway is organized by GCPlearning.

Who Will Benefit:

• Regulatory Affairs Personnel
• Quality Personnel
• Clinical Personnel
• Research Personnel
• Manufacturing Personnel
• Legal Personnel
• Personnel who require an understanding of the FDA Biosimilar process

Overview:
This web presentation presents an overview of the FDA's requirements for approval/marketing of a Biosimilar (Generic Biologic) product. The webinar covers the Biosimilar product testing requirements (clinical and non-clinical) and the Biosimilar approval pathway. The webinar also reviews the Regulatory/Scientific/Quality principles involved along with the 3 FDA Biosimilar guideline documents. In addition, the FDA Stepwise Approach and the FDA Totality of the Evidence concepts will be discussed. 

Why should you attend:
This web presentation is intended for those professionals that require knowledge about FDA's three major regulations GCP, GLP, and GMP.

• Regulatory Affairs Personnel
• Quality Personnel
• Research Personnel
• Clinical Personnel
• Legal Personnel
• Manufacturing Personnel
• Auditors
• Clinical Research Associates (Monitors)

Areas Covered in the Session:

• BPCI Act
• Define the terms Biosimilar and Interchangeability
• FDA's Stepwise Approach
• FDA's Totality-of-the - Evidence Approach
• The Biosimilar Approval pathway

Note: Access recorded version only for one participant; unlimited viewing for 6 months

Original Price: $300
Special Offer Price: $15