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Tuesday, October 16, 2018
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Clinical Trials Management (US & EU) Professional Certification Program (GCP00A1)

Certification Training Duration: 11 hours (the average time to complete the training program, including final assessments).
Credit Hours: See individual courses for credit hours assigned.
Self-paced Training: 24/7 access to course.
Enrollment Period: 6 months.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $1100.00

Description:

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 their career into clinical and regulatory management positions.

Assure Employee Compliance of GCP Standards: Courses included with this program are the following: 1) GCP: Preparing for an Audit or Inspection; 2) Clinical Trial Monitoring: Documentation Enclosure; 3) Clinical Trial Monitoring: Site Evaluation and Set-Up; 4) Clinical Trials and Drug Development; 5) Clinical Trial Preparation and Design; 6) ICH Good Clinical Practice (ICH: GCP); 7) The IND, How to Gain Approval for Clinical Trials in the USA; and 8) How to Obtain Approval to Conduct Clinical Trials in the EU.

The entire program must be viewed by students, and seven multiple-choice, online final assessments (one for each course included in the program) must be completed with a passing grade of 80% or more. Once the program requirements are succeeded, a professional certificate is immediately achieved. 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.

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.


Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com


BioPharma Institute LogoThe Clinical Trials Management (US & EU) Professional Certification Program includes these individual courses:



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 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


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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