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Saturday, January 19, 2019
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GCP: Introduction to Clinical Trials and Drug Development (GCP03)

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: Introduction to Clinical Trials and Drug Development
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. This online course provides an understanding of how clinical trials fit into the drug development process. It outlines the key historical events leading to the development of controlled clinical trials. It specifies the purpose of trials, outlines their features, and identifies codes and regulations that apply to them. Finally, it describes the environment of cost control in which the modern pharmaceutical industry operates.
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: Introduction to Clinical Trials and Drug Development 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

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


COURSE OUTLINE:


Overview: The context of the pharmaceutical industry and modern medicine is established. The course’s four perspectives on clinical trials are set out. History Factors that gave rise to the modern framework of regulation of clinical trials are traced.

Codes and regulations: The principal elements of regulation of clinical trials are set out. The regulatory frameworks of the USA, Europe and Japan are outlined. International harmonization of requirements through the work of ICH is discussed, with particular reference to Good Clinical Practice.

Drug development: The long and financially risky process of developing a drug is described. The various stages of discovery, nonclinical and clinical development are detailed. Global market Commercial considerations in drug development are described. Issues such as financial risk, pharmacoeconomics, patent life and generics are discussed.

COURSE OBJECTIVES:


Students completing this course should be able to: Summarize the key historical events leading to the development of controlled clinical trials, describe the purpose of a clinical trial. Outline the legislative and ethical framework. Describe how clinical trials fit into the drug development process. Outline the environment of cost control in which the modern pharmaceutical industry operates.


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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