Albert A. Ghignone
Instructor Albert A. Ghignone
Product Id 601120
Duration 90 Minutes
Version Recorded
Original Price $300
Special Offer Price $15
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Biosimilar (Generic) Biologics In The USA: Approval Pathway


This web presentation presents an overview of FDA's requirements for approval/marketing of a Biosimilar (Generic Biologic) product. The 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. In addition, the FDA Stepwise Approach and the FDA Totality of the Evidence concepts will be discuss.

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

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

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. He lectures throughout the world on numerous FDA related matters. He is a consultant to FDA and trains FDA Field Force (those who conduct FDA inspections) on GCP, GLP and GMP). In addition to training FDA personnel Mr. Ghignone also consults/trains for Drug, Biologic and Medical Device companies, US Army HIV Research Group, NIH AIDS Group, US Army Surgical Research Group and the Naval Medical Research Group. He is a member of the Regulatory Affairs Professionals Society which elected him the 1984 Professional of the Year. He has served the society as Vice President, President and Chairman of the Board of Directors.

In recent years he has filed numerous FDA drug, biologic and medical device submissions for product approval. In addition he has been involved in two of the largest clinical trials conducted, the 8,000 patient clinical trial in Africa and the 16,000 patient clinical trial in Thailand.

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