2014 - 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
Speaker Profile:
Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements.
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