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Tuesday, December 11, 2018
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GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA (GCP007)

Certification Training CPD Accredited TrainingCredits: 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

BioPharma Institute LogoTraining Program: GCP: Application Process to Conduct FDA-regulated Clinical Trials in 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 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.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information.


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: Application Process to Conduct FDA-regulated Clinical Trials in USA course is found in the following professional certification program(s):


Clinical Trials Management (US & EU) Professional Certification Program: This online professional certification program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates and coordinators with the desire to grow … Learn more

Obtaining Approval for Clinical Trials in US & EU Professional Certification Program: Clinical Trials Management (US & EU) Professional Certification Assures Employee Compliance of GCP Standards This professional certification program is designed for regulatory affairs managers, project 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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