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.
- 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
- 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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3 hours; 12:30 – 3:30 p.m. Eastern
April 6, 2010
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471