2014 - Webinar On The FDA Drug Approval Process

This web seminar provides an overview of the entire FDA Drug Approval Process. This seminar will cover FDA requirements from discovery.
We will begin by developing a molecule, testing it, going through the IND process, clinical testing and finally the NDA process. We will also discuss IND/NDA submission preparation, in-vitro studies, nonclinical studies and human clinical trials. Also discussed will be the underlying scientific and regulatory principles involved in the entire Drug Development Process. This web seminar will also provide a foundation of knowledge for those who require an understanding of the entire FDA Drug Approval Process.
Areas Covered in the Session :
Understand the FDA drug research requirements
Learn about IND process
Learn about Clinical testing requirements
Learn about NDA process
Learn about in-vitro and nonclinical testing
Who Will Benefit:
Regulatory Affairs Personnel
Quality Personnel
Clinical Personnel
Research Personnel
Manufacturing Personnel
Drug Discovery Personnel
Legal Personnel
Personnel who require a general understanding of the FDA Drug Approval 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
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