Albert A. Ghignone
Instructor Albert A. Ghignone
Product Id 601096
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

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.

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

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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