|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.
Training Program: GCP: How to Obtain Approval to Conduct Clinical Trials in the EU
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment. A sponsor wishing to conduct clinical studies with an investigational drug in the European Union must seek and gain approval before each phase of clinical development. This entails submitting a Clinical Trial Authorization (CTA) application to the regulatory Competent Authority of each Member State (MS) in which the clinical trial is to be conducted. At the same time, the sponsor must apply for a favorable opinion from the relevant Ethics Committee(s) in each MS. Only when the authorization and favorable opinion have been obtained can the trial commence. This online course provides regulatory professionals with knowledge necessary to enable them to complete and submit applications for CTA and for Ethics Committee (EC) favorable opinion to conduct a clinical trial. It also provides information on what to do to maintain approval if the circumstances of the clinical trial change.
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:
The GCP: How to Obtain Approval to Conduct Clinical Trials in the EU course is found in the following professional certification program(s):
Overview: The requirements for CTA and EC favorable opinion are introduced, and the scope and learning objectives of The course are specified.
Students completing this course should be able to: Explain what a Clinical Trial Authorization (CTA) application is, why it is required, and to which bodies it should be submitted. Explain what an application for an Ethics Committee (EC) Opinion is, why it is required and to which bodies it should be submitted. Describe the regulatory environment governing CTA applications and access the key regulatory documents. Summarize the information that should be included in the CTA and EC applications.
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.