Thursday 30th October, 2014
9:00am to 6:00pm
Lecture 1: Introduction To FDA: Laws and Regulations involved
Lecture 2: Definitions
Lecture 3: FDA Office of Combination Products
Lecture 4: What is a Combination Product
Lecture 5: Examples of Combination products
Lecture 6: Mode of Action and Primary mode of Action
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.
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