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Overview: 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. Attendees will receive a foundation of knowledge about FDA's Drug Development Process, 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 presentation will enable the attendee to prepare concise documents and provide FDA required information for fast product approval. Why Should You Attend: Professionals who require an understanding of the FDA Drug Development Process. Those professionals that require an understanding of what FDA requires relative to in-vitro, nonclinical and clinical studies. The necessary submissions required by FDA. An understanding of the entire FDA Drug Development Process is outlined for those who require this information. Areas Covered in the Session: Understand the FDA Drug Development Process Learn about INDs Learn about NDAs Learn the basics for in-vitro and nonclinical testing Learn the basics about human clinical testing Learn about FDA's IND/NDA review process Who Will Benefit: Regulatory Affairs Professionals Quality Professionals Clinical Professionals Research Professionals Manufacturing Professionals Other professional that require an understanding of the FDA Drug Development Process 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. Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Event Link - http://bit.ly/18n3cri
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