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Saturday, January 19, 2019
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GCP: The IND, How to Gain Approval for Clinical Trials in the USA (GCP07)

Certification Training 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.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: GCP: The IND, How to Gain Approval for Clinical Trials in the USA
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

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:

  • Immediate access to training: Instructions, user name, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced training: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The GCP: The IND, How to Gain Approval for Clinical Trials in the USA course is found in the following professional certification program(s):


Professional Designation in Clinical Trials Management: For Clinical Research Associates, Project Managers, and Clinical Managers. … Learn more


COURSE OUTLINE:


Regulatory overview: This session briefly describes the legislative guidelines that apply to obtaining FDA approval to conduct clinical trials in the USA.

An introduction to Investigational New Drug Applications: This session provides a brief overview of the IND and of the submission process.

IND content and format requirements: Explore the specific format and content requirements of an IND application as specified by the Center for Drug Evaluation and Research (CDER).

The IND review and approval process: This session discusses the FDA review principles for IND applications, with a view to improving your application.

Maintenance of an IND: This session outlines the different types of IND amendments, when they are required, and the regulations that govern them.

Summary: Key point summary for all topics covered in This online course. Ideal for review, a refresher or a consolidation of learning points.

COURSE OBJECTIVES:


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.

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