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 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.
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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 Melissa Dolen 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# 0778-0000-13-033-L01-P. Released: 10/13.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.