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Home » Regulatory Affairs: Electronic Common Technical Document (eCTD)

Regulatory Affairs: Electronic Common Technical Document (eCTD) (PRA04)

Certification Training
 
Rated 4.50/5
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Method of Training: Online / Self-paced eLearning.
Credits: 2.5 CPD Credits.
Duration: ~2.5 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Pharmaceutical Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $225.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

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

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


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 familiarize 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.

The Regulatory Affairs: Electronic Common Technical Document (eCTD) Course is Included in the Following Professional Certification Programs:


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

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

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