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

Regulatory Affairs: Electronic Common Technical Document (eCTD)

Certification Training
 
Rated 4.2 / 5
14 reviews
Program/Course ID: PRA04
Enrollment Period: 6 months.
Average Learning Time: ~150 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 2.5 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Pharmaceutical Regulatory Affairs.
Demonstration: Five (5) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $225.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a training certification.

Training 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 enrollment.

Description:
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.

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.


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.

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.

Regulatory Affairs: Electronic Common Technical Document (eCTD) is included in the following professional certification programs:



Professional Certification Program:

Global Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00A1
Price: $1795.00 (USD) | Learn more

Professional Certification Program:

US Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00B1
Price: $1295.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.

Group Training for Employees: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.


Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
  • Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
  • Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
  • Purchase orders (POs): If issuing 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.
  • Reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
  • 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.
  • Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.


Have Questions? Contact Us:

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