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Tuesday, December 11, 2018
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GCP: Clinical Trials and Drug Development (GCP003)

Certification Training CPD Accredited TrainingCredits: 1.5 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: 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 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 purpose of trials is specified and further explored through the regulations that apply to them, the identification of codes, and outlining their features. It discusses the environment of cost control in which the pharmaceutical industry of today operates.

Upon completing this course, students will be able to do the following: Provide an outline of the environmental cost control in which the pharmaceutical industry of today operates; give a description of how clinical trials fit into the process of drug development; outline the ethical and legislative framework; describe the purpose behind clinical trials; provide a summary of the key historical events which led to the development of controlled clinical trials.

The course contains a general overview, and sections regarding codes, regulations, and drug development.

The entire program must be viewed by students in order to pass. An online, multiple-choice final assessment score of 75% or better is required. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certificate of completion is immediately available.

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.

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: Clinical Trials and Drug Development 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:


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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