Drug Development and FDA Regulations

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Course Description

This course provides an overview of the drug development process including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (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 investigational drug 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.

Learning Objectives

  • 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 trials
  • Discuss briefly the requirements for an NDA
  • Explain briefly the post approval responsibilities of sponsors, including Phase 4 clinical trials
  • Describe the fundamentals of GLP, GCP, and GMP

Who Should Attend

  • Investigators
  • Site Study Team Members
  • Clinical Research Associates
  • 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.

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Course Outline

Day One: 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 trials)
  • Requirements for an NDA  
  • Post approval responsibilities of sponsor (Phase 4 clinical trial)  
  • Fundamentals of GLP, GCP and GMP  

Interactive Activities

  • Drug Development Process
  • Review of Form FDA 1571 for an IND application
  • Review of Form FDA 1572 for conducting a clinical trial
  • Review of Form FDA 356h for an NDA application

Registration Fees

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 Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.     

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Accreditation Information

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 issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-19-003-L01-P. Released: 5/19.


Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.