|Credits: 3 CPD Credits
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $145.00
Training Program: GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
The IND (Investigational New Drug) Application is a submission through which the sponsor seeks approval from the FDA (Food And Drug Administration) to conduct clinical studies with an investigational drug. This online course will give students who are, or are becoming, regulatory professionals, the necessary detail and background required in order to complete and submit, for FDA approval, an IND application. An IND must contain various pieces of information covering areas such as clinical protocol, manufacturing, toxicology, drug distribution, and animal pharmacology. The application is a stepping stone that is crucial, from nonclinical all the way to clinical testing.
Once all course requirements have been satisfied, a Certificate of Completion is immediately available. Course takers can attempt the final assessment any number of times, as needed in order to achieve a passing grade.
Benefits of Getting Certified at BioPharma Institute
By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. The BioPharma Institute has assisted companies both abroad and throughout the United States for two decades. Through various learning tools our online courses offer proven methods that can help individuals and/or companies stay on top of the latest changes in the clinical research, pharmaceutical, and healthcare industries.
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: Application Process to Conduct FDA-regulated Clinical Trials in 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:
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.