Webinar On FDA’s Biosimilar (Generic Biologics) Process

This web presentation presents an overview of FDA’s requirements for approval/marketing of a Generic Biologic (Biosimilar) in the USA. This webinar covers the Biosimilar product testing requirements (clinical and nonclinical) and the Biosimilar approval pathway. The webinar also reviews the Regulatory/Scientific/Quality principles involved along with the 3 FDA Biosimilar guideline documents. The FDA Step-wise Approach and the FDA Totality of Evidence concepts will also be discuss.

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

Who Will Benefit:

Regulatory Affairs Personnel

Quality Personnel

Clinical Personnel

Research Personnel

Manufacturing Personnel

Legal Personnel

Auditors

Clinical Research Associates

Personnel who require an understanding of the FDA Biosimilar process

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299