Conducting Clinical Trials Under ICH GCP
September 28-29, 2016
Philadelphia, PA
CRA & CRC: Beginner Program
September 27-29, 2016
San Francisco, CA
Auditing Techniques for Clinical Research Professionals
October 11-12, 2016
San Francisco, CA

Global GCP Monitoring: Domestic and International Compliance

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

Course Description 
This course examines global GCP compliance issues and GCP monitoring responsibilities. Participants explore GCP issues relevant to studies conducted within the US and abroad. There is a special focus on the culture issues impacting clinical research.  

Learning Objectives 

  • Describe FDA Good Clinical Practice in relation to clinical research 
  • Define ICH Good Clinical Practice in relation to clinical research 
  • Discuss the European Union Directive and GCP 
  • Review other selected countries monitoring bodies and responsibilities 
  • Assess the cultural impacts on monitoring responsibilities OUS 

Who Should Attend 

  • Clinical Research Associates 
  • Clinical Research Assistants 
  • Clinical Research Coordinators 
  • Principal and Sub-Investigators 
  • Quality Assurance and Other Regulatory Professionals 

The course will be led by one of the following instructors: 

Elizabeth Ronk Nelson, M.P.H.
Lily Romero, P.A., C.C.R.C.

Click here for complete trainer biographies 

Course Outline 

Day 1: 8:30 a.m. – 5:00 p.m. 

  • Introduction and Welcome 
  • Ethics in Clinical Research – An Overview 
  • FDA GCP 
  • ICH GCP 
  • European Union Directive and GCP 
  • Summary and Q&A 

Day 2: 8:30 a.m. – 5:00 p.m. 

  • Specific Country Regulatory Bodies 
  • Culture Impacts on GCP 
  • GCP Exercises 
  • Wrap-up and Course Evaluation 

Interactive Activities 

  • Shared Participants’ Good Monitoring Practices 
  • Examination of Real Life Scenarios 
  • Review of FDA Q&A Information Sheet 


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 issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-13-033-L01-P. Released: 10/13. 


Hold this course at your company! 

For more information, contact Naila Ganatra at (215) 413-2471.