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Conducting Clinical Trials Under ICH GCP

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

Course Description 

This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining an ongoing relationship with the FDA will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for the clinical studies. 

Learning Objectives  

  • Summarize FDA GCP regulations 
  • Recognize how GCP impacts the clinical research process 
  • Prepare concise documents and provide necessary information for the clinical studies 
  • Maintain an ongoing relationship with the FDA 

Who Should Attend 

  • This course is intended for Clinical, Regulatory, and Quality Personnel who require an understanding of the GCP regulations and requirements. This course will also benefit other personnel who must be familiar with the essentials of the clinical process and requirements. 

Instructor 

Albert A. Ghignone, M.S., R.A.C. 

Click here for complete trainer biographies 

Course Outline 

Day One: 8:30 a.m. – 5:00 p.m. 

  • Introduction to ICH and FDA GCPs: History; law; regulations; definitions; FDA organization; bioresearch monitoring group; evolution of GCP; ICH process 
  • Clinical Research Process – A Discussion and Overview of the Whole Process and Where GCP Interact: IND process; clinical research process; clinical studies 

Day Two: 8:30 a.m. – 5:00 p.m. 

  • USA Good Clinical Practice: Sponsor responsibility; investigator responsibility; IRB responsibility 
  • ICH: Sponsor responsibility; investigator responsibility; ethics committee responsibility 

There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day. 

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 15 hours (1.5 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# 0778-0000-13-030-L01-P. Released 9/13. 

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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Informed Consent Content & Process Requirements for Biobanking Studies 

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Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


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)