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Home » GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA

GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA (GCP007)

Certification Training
 
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Method of Training: Online / Self-paced eLearning.
Credits: 3 CPD Credits.
Duration: ~3 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $225.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

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

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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 passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


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.

The GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA Course is Included in the Following Professional Certification Programs:


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: This professional certification program is designed for regulatory affairs managers, project managers, or clinical research associates and coordinators with desire to grow their career into these positions. Cou ... Learn more

Full List of Programs in the Clinical Trials Management and Monitoring Catalog:



Clinical Trials Monitoring Professional Certification Program: GCP, or Good Clinical Practice, refers to a set of scientific and ethical quality standards for reporting, recording, conducting, and designing trials that involve human subjects. GCP compliance ensures the wel ... Learn more

Obtaining Approval for Clinical Trials in US & EU Professional Certification Program: This professional certification program is designed for regulatory affairs managers, project managers, or clinical research associates and coordinators with desire to grow their career into these positions. Cou ... Learn more

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

GCP: ICH Good Clinical Practice (ICH-GCP), An Abridged Course: The pharmaceutical industry is currently undergoing a large number of regulatory changes. Individuals that are involved in research will be directly affected. As we carry out our duties there is always the risk ... Learn more

GCP: ICH Good Clinical Practice (ICH-GCP): Many regulatory changes are happening in the pharmaceutical industry. Those who are particularly affected are individuals involved in research. When carrying out research duties, there is always the risk of bre ... Learn more

GCP: Clinical Trial Preparation and Design: Worldwide expenditure by pharmaceutical companies on research and development is continually increasing. In the production of a new drug, most of the financial investment is allocated to clinical trials. It is ... Learn more

GCP: Clinical Trials and Drug Development: This online course teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials is outlined. The ... Learn more

GCP: Clinical Trial Monitoring: Site Evaluation and Set-up: Site evaluation and the set-up's purpose is to ensure that the site is fully prepared for the conduct of the clinical trial, facilitates to conduct the study, has adequate time and appropriately qualified staff ... Learn more

GCP: Clinical Trial Monitoring - Documentation and Closure: Once the initiation of a trial begins, the CRA (clinical research associate) has a crucial role which is to monitor the conduct of the trial, as well as the recorded data's integrity. This online course will fa ... Learn more

GCP: Preparing for an Audit or Inspection: In order to ensure compliance with GCP (Good Clinical Practice), clinical trial sites of investigators and sponsors are subject to rigorous inspection by regulatory agencies. In this course, United States and E ... Learn more

GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA: 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 ... Learn more

GCP: How to Obtain Approval to Conduct Clinical Trials in the EU: Before each phase of clinical development, approval must be sought and gained for any sponsor desiring to conduct investigational drug clinical studies in the European Union. This online course enlightens regul ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization

Contact Us:

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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