This web seminar provides an overview of the drug development process. Included are the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (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
- Clinical Research Associates
- Regulatory Affairs Professionals
- Quality Assurance Personnel
- Manufacturing Personnel
Albert A. Ghignone, M.S., R.A.C.
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 3 hours (0.3 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-13-007-L01-P. Released: 3/13.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.