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.
- Summarize Good Clinical Practice (GCP) & Clinical Research Team Roles and Responsibilities
- Recognize how GCP impacts the clinical research process through review of key documents and necessary information for clinical trials
- Apply concepts of root cause analysis and corrective and preventive actions for quality management
- Discuss key elements for monitoring reports and written documentation in GCP
- Review regulatory compliance, audit preparation and inspections
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.
Nikki Christison, B.S., C.C.R.A.
Gary B. Freeman, M.S., C.C.R.A.
Janet Ellen Holwell, C.C.R.C., C.C.R.A.
Lily Romero, P.A. C.C.R.C.
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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 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 issue a receipt of completion for earned CEUs 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.