Course Overview
This course is designed to interpret FDA regulations and ICH guidelines to apply to informed consent, adverse event and drug accountability reporting, ethical conduct during clinical research and to define the IRB/ED’s. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines.
You should expect to spend approximately 3 hours of study time to complete the course.
Course Details
2-Month Access
Course Rate: $240.00
Please have your credit card ready in order to complete registration.
Key Topics
- Regulatory Environment in the United States
- International GCP Regulations
- Institutional Review Boards/Ethics Committees
Educational Objectives
- Interpret FDA regulations and ICH guidelines pertaining to GCPs
- Apply GCP regulations and guidelines to your processes around informed content, adverse event reporting, records and reports, and drug accountability
- Describe the IRB/EC responsibilities for ensuring the ethical conduct of clinical research
Who Should Attend
- Study site investigators
- Site monitors and auditors
- Research nurses
- Regulatory affairs associates
- Data management personnel
- Pharmacists
Continuing Education Credits
Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for attendance at this program. To receive credit, you must attend the entire program and submit the Continuing Education Application form directly to a PERI on-site coordinator. Additional $35 fee applies for students who are applying for continuing education credit.
Continuing Medical Education (CME)
PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Pharmacy Education (CPE)
Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This is a knowledge based CPE activity.