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Comparing FDA and Health Canada Regulations: Using an ICH GCP Framework

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

Course Description

Protection of human research subjects and data integrity are the two central tenets of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) worldwide. In this interactive web seminar you will learn how the U.S. Food and Drug Administration (FDA) and Health Canada have interpreted ICH GCP guidance. Case studies and other interactive techniques will be used to provide participants with a deeper understanding of clinical research requirements and best practices according to the FDA and Health Canada drug regulations. This web seminar will provide an in-depth focus on drug regulations.

Learning Objectives

  • Review key guidance documents: The Belmont Report (U.S.) and the Tri-Council Policy Statement (Canada)
  • Describe the similarities and differences in Institutional Review Boards and Research Ethics Boards
  • Determine investigator and sponsor obligations
  • Examine essential documentation; from informed consent to archiving requirements
  • Discuss inspection process and recent findings
  • Implement best practices in conducting clinical studies according to the FDA and Health Canada drug requirements

Who Should Attend

  • Site Research Managers and Coordinators
  • Investigators
  • Clinical Research Monitors
  • Project Managers
  • Clinical Research Associate Managers
  • Clinical Research Directors
  • Regulatory Affairs Professionals

Instructor

Natalie Currie, BSc.

Click here for complete trainer biographies 

Registration Fees

$695

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.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 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#: 0778-0000-11-068-L01-P.  Released: 8/11. 

                                              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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Blended Curriculum Path for the CRA, CRC, and Project Manager

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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)