|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: Pharmaceutical Regulatory Affairs: Electronic Common Technical Document (eCTD)
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment. The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of registration dossiers. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This online course details the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. This relatively new aspect of submissions will undergo rapid and significant change as specifications are modified and refined further. The eCTD course is an excellent reference and training tool and will assist anyone involved with electronic submissions in navigating these changing requirements.
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 Pharmaceutical Regulatory Affairs: Electronic Common Technical Document (eCTD) course is found in the following professional certification program(s):
Introduction: This session defines the eCTD and identifies advantages of using this submission format.
Students completing this course should be able to: Describe the structure, requirements and functionality of the eCTD. Outline XML basics and the architecture of the eCTD. Discuss Document Type Definitions (DTDs). Explain how to build an eCTD. Specify regional differences. Discuss life cycle and change management. List criteria that will make an electronic application technically valid. Initiate electronic transfer to a regulatory authority. Create, submit and maintain an eCTD dossier throughout the life of a drug product.
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.