This course provides an overview of the drug development process including GLP, GCP, and GMP processes. It is ideal for early stage investigators from varied disciplines and new industry professionals with a need to develop an understanding of the drug development process. The course will review the steps that lead up to the clinical trial process. It will discuss the phases of clinical development that are part of the IND (the actual human trials that are conducted to demonstrate safety and efficacy to allow the regulatory authorities reason to approve the investigationaldrug for marketing). The NDA process will then be reviewed with insight into possible post-NDA activities that may be requested. The included workbook is a great tool for reference purposes.
Discuss the FDA’s role in drug development
Explain the logic of the drug development process
Cite the basics of non-clinical drug testing
Discuss briefly the requirements for an IND
Cite the basics of clinical trial structure and design, including Phase 1, 2, and 3 clinical studies
Discuss briefly the requirements for an NDA
Explain briefly the post approval responsibilities of sponsors, including Phase 4 clinical studies
Describe the fundamentals of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP)
Investigators
Site Study Team Members
Clinical Research Associates (CRAs)
Regulatory Affairs Associates
Project Managers
New industry professionals with a need to understand the drug development process
The course will be led by one of the following instructors:
Gary B. Freeman, M.S., C.C.R.A.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Introduction
- FDA’s Role in Drug Development
- Logic of drug development
- Basics of non-clinical drug testing
- Requirements for an IND
- Basics of clinical trial structure and design (Phase 1, 2, 3 clinical)
- Requirements for an NDA
- Post approval responsibilities of sponsor (Phase 4 clinical)
- Fundamentals of GLP, GCP and GMP
Drug Development Process
Review of Form FDA 1571 for an IND application
Review of FDA Form 1572 for cnducting a clinical trial
Review of Form FDA 356h for an NDA application
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 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# 0778-0000-13-026-L01-P. Released: 5/13.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.