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Drug Development and FDA Regulations

Please check back later for this seminar's current schedule, or review our other live seminars for similar courses.

Course Description 

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. 

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 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) 

Who Should Attend
 

  • 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 

 Instructor 

Gary B. Freeman, M.S., C.C.R.A. 

Click here for complete trainer biographies 

Course Outline 

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 

Interactive Activities 

  • 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

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. 

Click here for our seminar cancellation policy 

Accreditation Information

ACPE LogoBarnett 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. 

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On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.


GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 


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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)