Duration: 2 hours, Online (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.
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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.
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.
Technical infrastructure: This session gives information on XML specification and style sheets and describes the eCTD backbone. Directory structure: This session looks at the eCTD hierarchy, lifecycle management and structure of the five courses.
Submitting an eCTD: This session explores the workflow around planning and submitting an eCTD, particularly setting up The courses, migrating and validating the data, preparing the covering letter and submitting some eCTD parts on paper. It also reminds learners that a correctly completed eCTD is a valid legal document.
Additional DTDs Canadian, EU, Japanese, American and STF: DTDs are described.
Tools: This session includes a case study and an eCTD Checklist to assist learners when compiling an eCTD submission.
Summary: Key point summary for all topics covered in The course. Ideal for a refresher or consolidation of learning points.
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.
Online Training Program Benefits:
- Immediate access to training: Instructions, username, 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 courses: 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
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- 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
- Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- 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.