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.
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
Clinical Research Coordinators
Clinical Research Associates
Principal and Sub-Investigators
Clinical Research Assistants
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.
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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
Shared Participants’ Good Monitoring Practices
Examination of Real Life Scenarios
Review of FDA Q&A Information Sheet
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 Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett 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# 0778-0000-10-011-L01-P. Released: 10/10.
This continuing nursing education activity was approved by New Jersey State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s COA. Approval Number: 7048-12/10-12. 14 Contact Hours.
There is no commercial support for this activity. Speakers have declared that they have nothing to disclose. Accredited status does not imply endorsement by Barnett International, NJSNA or ANCC of any commercial products or services.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.