Speaker Profile

Albert A. Ghignone

Chief Executive Officer and President, AAG Incorporated

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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Comparison of GCP, GLP and GMP; FDA's Three Major Regulation

This web presentation presents an overview of FDA's three major regulations - Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Although varying slightly in different regions of the world these three regulations have the same basic elements and interpretations globally.

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The FDA Drug Development Process

This web presentation will provide the attendee a comprehensive overview of the FDA Drug Development Process, IND/NDA applications and GCP, GLP and GMP regulations.

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  •     $10.00
FDA's New Breakthrough Therapy Designation Program and Other FDA Expedited Programs

This webinar will discuss four FDA expedited programs intended to facilitate and expedite development, review and approval of new drugs to address unmet medical needs in the treatment of serious and life-threatening conditions. This webinar includes FDA's newest expedited program Breakthrough Therapy Designation. Besides Breakthrough Therapy Designation also discuss will be Fast Track Designation, Accelerated Approval and Priority Review Designation.

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  •     $15.00
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.

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