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Sunday, December 16, 2018
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Regulatory Affairs: Electronic Common Technical Document (eCTD) (PRA04)

Certification Training CPD Accredited TrainingCredits: 2.5 CPD Credits
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Pharmaceutical Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $195.00

BioPharma Institute LogoTraining Program: Regulatory Affairs: Electronic Common Technical Document (eCTD)
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

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 medicinal product dossiers for regulatory applications. 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 module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. The module provides a training and reference tool that will be of particular value to those new to the use of the format.

This online course details the Electronic Common Technical Document specification, provides guidance on the creation of the submission of an eCTD, and discusses the approach to regional differences in dossiers. This relatively fresh aspect of submissions will undergo significant and rapid changes as specifications are refined and modified further. This class is a superb training tool and reference and can be of assistance to anyone involved with electronic submissions and in navigating these changing requirements.

Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can attempt the final assessment any number of times, as needed, in order to achieve the required 75% or better 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.


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 Regulatory Affairs: Electronic Common Technical Document (eCTD) course is found in the following professional certification program(s):


International Pharmaceutical Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ … Learn more

US Pharmaceutical Regulatory Affairs Professional Certification Program: This online professional certification program describes the essential requirements for obtaining approval of a new drug in the USA, the ‘NDA Process’. The program describes preparing submissions using the Comm … Learn more


COURSE OUTLINE:


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, life cycle management and structure of the five modules.

Creating an eCTD submission – This session explores the workflow around planning, creating and submitting an eCTD – particularly setting up the modules, and migrating and validating the data.

Special components – Features of the Canadian, EU, Japanese and US DTDs/schemas and the STF specification are outlined.

Tools – This session includes a case study and an eCTD checklist to assist learners when compiling an eCTD submission.

Assessment – Multiple-choice mastery assessment.

COURSE OBJECTIVES:


Who will benefit from this module?

This module is an essential tool for regulatory affairs and compliance staff and specialists in data handling, knowledge management or documentation. All those involved in drug development and who contribute to regulatory submissions will also wish to familiarise themselves with its contents.

Objectives

  • Describe the structure, requirements and functionality of the eCTD.
  • Outline XML basics and the architecture of the eCTD.
  • Discuss Document Type Definitions (DTDs) and schemas.
  • 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.

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