|Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
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Contact the BioPharma Institute for more information.
Training Program: GCP: The IND, How to Gain Approval for Clinical Trials in the USA
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment. The Investigational New Drug (IND) application is a submission to the Food and Drug Administration (FDA) through which the sponsor seeks approval to conduct clinical studies with an investigational drug. The IND application is the crucial stepping stone from non-clinical to clinical testing. The IND must contain information on a number of areas including animal pharmacology, drug distribution, toxicology, manufacturing, and the clinical protocol. This online course will provide regulatory professionals with the background and necessary detail needed to complete and submit an IND application for FDA approval.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
Online Training Programs Include:
The GCP: The IND, How to Gain Approval for Clinical Trials in the USA course is found in the following professional certification program(s):
Regulatory overview: This session briefly describes the legislative guidelines that apply to obtaining FDA approval to conduct clinical trials in the USA.
Students completing this course should be able to: Describe what an IND is, and why it is needed. Access the key regulatory documents surrounding INDs. Describe the content and format of an IND application. Describe the IND review and approval process. Describe the IND reporting requirements, and the types of amendments that can be made to an IND.
For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.