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Drug Development and FDA Regulations April 2010

Course Description

This course provides an overview of the drug development process. Included are the GCP, GLP, and GMP regulations and how they interact in the drug development process.



Learning Objectives

  • Describe the FDA’s Role in Drug Development
  • Review the logic behind the drug development process
  • Discuss IND/NDA submissions
  • Describe the basics of the clinical trial process
  • Describe the FDA review process for IND/NDA submissions
  • Navigate the three major FDA Regulations: GCP, GLP and GMP

Who Should Attend

  • Those who want an understanding or greater understanding of the drug development process
  • CRAs
  • Auditors
  • Regulatory Affairs Professionals
  • Quality Personnel
  • Manufacturing Personnel


Albert A. Ghignone, M.S., R.A.C.

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Course Length Time

3 hours; 12:30 – 3:30 p.m. Eastern

Course Dates

April 6, 2010

 Hold this course at your company!

 For more information, contact Naila Ganatra at (215) 413-2471